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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2020 and (b)(6) 2020.Device evaluation: product evaluation was not performed because the product has not yet been received.If product is received after initial closure, the ir and complaint file (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be verified and no product deficiency could be identified.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.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 the lens was explanted from patient left eye due to unhappy with post-op outcome.There was incision enlargement.No sutures or vitrectomy were required.Lens was implanted with a non-johnson and johnson lens, 14.0diopter power as replacement.No further information provided.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation ¿ yes, returned to manufacturer on 1/25/2021 section h3: device returned to manufacturer ¿ yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during explant.The lens was cleaned, and no cosmetic issues were observed.The complaint issue could not be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaints have been received for this production order number.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: TECNIS 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: 11205934
• Report Number: 2648035-2021-07106
• Device Sequence Number: 4759889
• Product Code: HQL
• UDI-Device Identifier: 05050474528901
• UDI-Public: (01)05050474528901(17)241125
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention