MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: unknown as there is no indication that lens was implanted.If explanted, give date: unknown as there is no indication that lens was implanted.Hence, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a customer had a problem with 2 ar40e intraocular lens (iol) today during a case.The haptic broke off during insertion of each lens.The staff did save the pieces of lens from the case.Follow-up noted that the patient is doing okay.A dcb00 5.0d iol was implanted as back-up iol.It was learned that how the event occurred was as the lens was loaded in the unfolder, with haptics intact.When folding the wings, it seemed to bevel, instead of folding like a "taco".But it was noted that the haptic was not visibly detached.It was also confirmed that there was patient contact.No other information was provided.This mdr report pertains to one of the suspect ar40e iol.A separate report will be submitted to capture the other suspect ar40e iol.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes returned to manufacturer on: 4/15/2021 section h3.Device evaluated by manufacturer? yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in pieces, which is consistent with a lens that was removed from the cartridge tip before insertion.Haptic damage (both bent and one haptic with broken off loop material, but not from the drill hole).Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue was confirmed, however this can be attributed to handling and cannot be confirmed to be related to manufacturing.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11627996
• Report Number: 2648035-2021-07496
• Device Sequence Number: 11679472
• Product Code: HQL
• UDI-Device Identifier: 05050474501874
• UDI-Public: (01)05050474501874(17)250916
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2025
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1