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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown.Explanted date: information unknown.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and 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 specifications.A search revealed that no other complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.Attempts were made to obtain the missing information; however, it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the iol (intraocular lens) was explanted due to the patient experiencing significant halos and poor contrast sensitivity.The replacement lens is a different model but same diopter, dcb00 19.0 diopter.There were no patient injuries or medical interventions such as capsule tear, incision enlargement, vitrectomy or sutures.The explanted iol was discarded and will not be returned for evaluation.Post-operative, the patient is reported as better visual symptoms.Reportedly, the customer cannot provide any further information therefore no follow-up is needed.No further information was provided.

• 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: 16457528
• Report Number: 3012236936-2023-00417
• Device Sequence Number: 15067554
• Product Code: MFK
• UDI-Device Identifier: 05050474560062
• UDI-Public: (01)05050474560062(17)241122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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: 11/22/2024
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0190
• Was Device Available for Evaluation?: No
• 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: 02/07/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male