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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to a mechanical failure.A vitrectomy and an incision enlargement were required, however, there were no sutures needed.There was no patient injury.Through follow-up, it was learned that the mechanical issue was due to the patient reporting constant blurred vision at all focal points and constant halos with vision, especially with night driving.The halos were so severe, the patient reported she felt unsafe driving.A non-johnson & johnson lens was successfully implanted as a replacement.The patient is stable post-operatively.No other information was provided.
Additional Manufacturer Narrative
Patient information unknown/not provided.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints 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.Attempts were made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: feb 7, 2023.Device evaluation: the complaint lens was received wrapped in gauze.The complaint lens was received coated in viscoelastic residue.The lens was cleaned and, no issues that could cause or contribute to the complaint issues could be identified.The complaint issues were not confirmed.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Corrected data: in the initial mdr section h6 investigation codes were inadvertently not populated with codes 3331 and 4109.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16308471
• Report Number: 3012236936-2023-00173
• Device Sequence Number: 6791987
• Product Code: MFK
• UDI-Device Identifier: 05050474750449
• UDI-Public: (01)05050474750449(17)241031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 03/05/2023

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: 10/31/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female