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

Model Number	Z9002
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, and ethnicity: unknown, information not provided, implant date: give date: n/a (not applicable).There is no indication that the intraocular lens was implanted.Explant date: if explanted, give date: n/a (not applicable).There is no indication that the intraocular lens was implanted; therefore, not explanted.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that surgeon noticed a tear in the intraocular lens (iol) when inserting the lens into the patient's eye.They could not determine if the tear was already there or if it happened while loading the lens into the inserter and cartridge.No further information is available.A replacement lens of the same model and diopter was implanted in the patient's eye with no problem.The surgery went great and no medical intervention was required.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation ¿ yes, returned to manufacturer on 09/28/2021.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 half, which is consistent with a lens that was handled during removal.The optic body was observed to be torn near a haptic.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue was confirmed, but can be attributed to handling and cannot be confirmed to be related to manufacturing and therefore no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL 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: 12451985
• Report Number: 2020664-2021-07265
• Device Sequence Number: 11746152
• Product Code: HQL
• UDI-Device Identifier: 05050474530720
• UDI-Public: (01)05050474530720(17)260422
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 04/22/2026
• Device Model Number: Z9002
• Device Catalogue Number: Z900200215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE PSCS, LOT CJ16513.; CARTRIDGE PSCS, LOT CJ16513