Model Number MA50BM |
Device Problem
Break (1069)
|
Patient Problems
Capsular Contracture (1761); Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
Evaluation summary: the iol product history records were reviewed and documentation indicates the product met release criteria.Cartridge product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A customer reported after implanting an intraocular lens (iol), the haptic broke.The lens was removed during the initial procedure, however, the broken haptic had 'hurt' the patient's capsule resulting in the patient experiencing a capsular rupture.Additional information was requested.
|
|
Manufacturer Narrative
|
The lens was returned for evaluation.Solution and blood are dried on the lens.One haptic is broken in the distal area (not returned).The other haptic is missing due to optic damage at the haptic insertion area.The optic has been cut in half which is consistent with insertion and removal.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a non-qualified company ii (b) cartridge and company ii handpiece.The lens model is only qualified for use in the monarch (a) cartridges.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge combinations.The root cause is most likely related a failure to follow the dfu.The account used an unqualified lens/cartridge combination.The use of non-qualified combinations may result in delivery issues and/or damage.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|