MDR Guidance Document No. 1 - IOL - E1996004
|Reference:||(1) Medical Device Reporting (MDR) regulation, 21 CFR 803, for manufacturers and user facilities (effective July 31, 1996) implements the requirements of the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.|
(2) Medical Device Distributor Reporting (MDDR) regulation, 21 CFR 804, for distributors, including importers.
|Purpose:||This document establishes Office of Surveillance and Biometrics (OSB) policy for determining when an event involving an Intraocular Lens (IOL) should be reported under MDR as a serious injury and when it should be filed as a malfunction. Guidance is also provided concerning record keeping requirements.|
|Product:||An Intraocular Lens is defined in 21 CFR 886.3600 as a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye. FDA has assigned product code 86 HQL to this device.|
|Background:||The initial guidance for IOLs was issued by OSB in an MDR Guidance Document dated May 23, 1994. That policy was revised and reissued May 15, 1995 as a result of comments received. The current revision incorporates changes under the 1993 MDDR and the 1996 MDR regulations such as (1) the removal of references to injuries that necessitate intervention to relieve temporary impairment/damage, (2) the addition of references to the responsibilities of user facilities and distributors, and (3) the removal of references to the caveats for not reporting malfunctions (under the 1984 MDR regulation).|
Intraocular lenses are Class III devices which require an approval under section 515 (premarket approval or PMA) of the Federal Food, Drug, and Cosmetic Act, as Amended (FD&C Act) before the product may be marketed. The manufacturers of these devices are required to submit MDR reports when they receive or otherwise become aware of oral or written information that reasonably suggests that their marketed device may have caused or contributed to a death or serious injury or there is a malfunction which is reportable under the MDR regulation.
Under 21 CFR 803, user facilities are required to report to the FDA and the manufacturer when they become aware of information that reasonably suggests that a device may have caused or contributed to the death of a patient of the facility. The user facility is required to report to the manufacturer (or to FDA if the manufactureris unknown) when they become aware of information that reasonably suggests that a device may have caused or contributed to a serious injury to a patient of the facility. There is no requirement under SMDA for user facilities to report malfunctions where there has been no serious injury.
Reporting obligations of distributors, including importers, of IOLs are currently found under 21 CFR 804. Under that regulation, importers are required to submit MDR reports when they receive or otherwise become aware of information that reasonably suggests that the device may have caused or contributed to a death or serious injury or there is a malfunction which is reportable under the MDR regulation. A distributor, other than an importer, is required to submit MDR reports when they receive or otherwise become aware of information that reasonably suggests that there is a probability that the device has caused or contributed to a death, serious illness, or serious injury or there is a malfunction which is reportable under the MDR regulation. In the future, FDA intends to publish a proposal in the Federal Register to recodify distributor reporting under 21 CFR 803.
The IOL PMA approval letter and regulation may have other event reporting requirements which are outside the scope of this guidance document. MDR reporting obligations do not apply to investigational devices; devices exported under an approved IDE are not subject to MDR (21 CFR 803.19). Devices which are legally exported under Export Approval Letters, and which are not under an approved IDE, are considered to be in interstate commerce and are subject to MDR reporting as marketed devices, even though the product may not be marketed in the U.S.A.
A malfunction is defined in 21 CFR 803.3(m) as a failure of a device to meet its performance specifications or otherwise to perform as intended. Malfunctions must be evaluated by the manufacturer to determine whether a similar malfunction is likely to cause or contribute to a death or serious injury. It is expected that manufacturers conduct follow-up investigations of reported complaints, including an analysis of failure rates, to meet the complaint handling requirements of the Good Manufacturing Practices (GMPs), 21 CFR 820. Such information would be necessary to support any contention by a manufacturer that a certain malfunction is not likely to cause or contribute to a death or serious injury and therefore is not reportable.
The MDR Guidance Document for IOLs issued May 23, 1994 concluded that haptic breakage which did not cause or contribute to a serious injury was considered MDR reportable as a malfunction as noted below in items 4(b) through 4(e). Although the events are considered reportable malfunctions, FDA has determined at this time that, pursuant to 21 CFR 803.19, MDR malfunction reports are not required for events where all three of the following conditions are met: a) haptic breakage takes place before the surgical procedure is completed, b) there is not an increase in frequency, and c) there is no surgical intervention required (such as enlargement of the incision or the scheduling of an additional surgical procedure). For any haptic breakage malfunction that does not meet all three conditions, an MDR malfunction report would still be required
Although MDR reports will no longer be required in all cases for the type of malfunctions noted in 4(b) through 4(e), manufacturers will still need to handle these incidents as complaints under 21 CFR 820 and document that an MDR report was not filed due to this policy. Also, FDA will continue to encourage the reporting of this type of problem by user facilities, since this information may alert the manufacturer to a problem with their product.
The following guidance should be used in determining when an event is reportable as a serious injury or malfunction.
- When a health care professional states that the performance of the IOL (including any malfunction) caused or contributed to a serious injury of a patient: The event should be considered reportable as a serious injury, unless found to be not reportable in accordance with 21 CFR 803.20(c)(2).
- When the health care professional states that there was a device malfunction, but states it did not cause or contribute to any patient serious injury or does not supply any information on the incident: The complaint file should document the reasons the health care professional believes the device malfunction did not cause or contribute to an injury. The firm must determine from this information whether the event meets the definition of a serious injury as defined in 21 CFR 803(aa). If it does, the firm must submit a serious injury report. If it does not, the firm's files should reflect the basis for determining that the malfunction did not cause or contribute to an injury. In the absence of a serious injury or death, the submission of a malfunction report is required if the malfunction is likely to cause or contribute to a death or serious injury if it were to recur.
- Reports of IOL damage and scratches may not be reportable in cases where the damage is clearly caused by the health care professional and does not result in a serious injury to the patient. A firm needs to have documentation in its files to confirm that this damage is attributable to the health care professional and is not an event where the device has malfunctioned within the meaning of MDR. For further guidance involving IOL damage which occurs during the procedure to implant the IOL, see item 4 which discusses haptic breakage.
Haptic breakage not clearly caused by the implanting physician or other health care professional is reportable depending on when the breakage occurred and whether there was a patient serious injury or a potential for a patient serious injury:
a) When surgical intervention is required to replace a lens with a broken haptic, the event meets the MDR definition of a serious injury because it necessitates surgical intervention to preclude a permanent impairment of a body function.
b) When the haptic breaks during implantation, and the lens is in contact with the patient, there is a potential risk of injury to that patient from:
- the damaged lens,
- the broken haptic, or
- the efforts made to remove the broken parts.
- Such an event would be reportable as a malfunction, as long as the information from the reporter specifies that there was no serious injury to the patient and no surgical intervention (such as enlargement of the incision or the scheduling of an additional surgical procedure) was required to replace the lens.
- c) When haptic breakage occurs, but the physician:
- determines that the lens is stable with no impairment of vision or other adverse effect/complication, and
- leaves the lens in place, the event is not reportable as a serious injury, but would be reportable as a malfunction.
d) When complaints state that the loop or haptic was broken, but do not contain information to identify when this occurred/was observed, the events should be investigated and the results documented. When the firm has made a good faith attempt to investigate the event and does not have information that there was a serious injury, the event may still represent a reportable malfunction.
e) When a broken haptic is identified at the time the package is opened or when the lens is removed from the case, but the lens is not used, the event is reportable as a malfunction.