MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC II 1-PIECE ACRYLIC; TORIC IOLS

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Was reported that a zxr00 20.0 diopter intraocular lens was explanted from the patient¿s right eye due to myopia.The patient is not bothered by any dysphotopsia and loves her first eye surgery with a the symfony lens, but the eye turned out plano so the doctor attempted to improve her near vision by implanting a piggy back lens.This resulted in the patient being too myopic.Therefore, the doctor decided to explant the iol and replaced it with the same model but a lower diopter 19.0.A vitrectomy was required.Thru follow-up the customer also explained that the patient¿s capsule did not tear, patient had a 1-2 clock hour zonluar dialysis with a few vitreous strands entering the anterior chamber that required a limited anterior vitrectomy.The lens was perfectly stable and on axis.Further follow-up was conducted but the customer did not have any more information regarding this issue.Reportedly, the patient is doing well.No further information was provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: TECNIS TORIC II 1-PIECE ACRYLIC
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9532341
• Report Number: 9614546-2019-01137
• Device Sequence Number: 2641652
• Product Code: HQL
• UDI-Device Identifier: 05050474657793
• UDI-Public: (01)05050474657793(17)240827
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020
• Report Date (Section F): 01/01/2005

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: 08/27/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 11/04/2020
• 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
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005