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

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information unknown/not provided.Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2020 and (b)(6) 2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to the patient experiencing symptomatic residual hyperopic astigmatism.Date of first symptoms was asked, but unavailable.There was no vitrectomy, incision enlargement, or sutures required.There was no patient injury.Another johnson & johnson lens (different model and higher diopter) was implanted as a replacement.The patient is doing fine post-operatively.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes returned to manufacturer on: 5/6/2021 section h3: device evaluated by manufacturer¿ yes device evaluation: the complaint lens was received in a different serial numbers lens case.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in pieces (not all pieces were received), which is consistent with a lens that was handled during explant.Based on the condition of the returned lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the clinical code 2138 unexpected postop refraction provided on the initial report needs to be corrected.Clinical code 2138 unexpected postop refraction is no longer applicable.The correct clinical code is 2330 sub-optimal results.The following section have been updated accordingly: section h6: health effect - clinical code: 2330 sub-optimal results.All pertinent information available to johnson and 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
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11638971
• Report Number: 2648035-2021-07558
• Device Sequence Number: 3099954
• Product Code: HQL
• UDI-Device Identifier: 05050474530867
• UDI-Public: (01)05050474530867(17)250428
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 04/28/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 08/28/2022
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 06/14/2021; 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male