MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: unknown/ not provided.(b)(4).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 intraocular lens was explanted from a patient¿s left eye (os) in secondary surgical procedure due to dysphotopsia.The symptoms did not significantly interfere with patient's daily activities.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 04/13/2020.Device evaluation: the complaint lens was returned to the manufacturer for evaluation.The lens was not returned in its original package.Visual inspection using magnification was performed to the returned sample and the lens returned was found cut in two pieces.Loose fibers/particles were observed on lens pieces related the handling of the unit out of a sterile environment.The condition in which the sample returned is consistent with a lens that was implanted and explanted.Due to the conditions of the lens returned, the complaint issue reported could not be verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing record review: the manufacturing record was reviewed; no deviation or discrepancies were found during the mrr (manufacturing record review).The product was manufactured and release according to the specifications.A search in complaint system revealed no additional complaint folders have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9935701
• Report Number: 2648035-2020-00332
• Device Sequence Number: 10950727
• Product Code: HQL
• UDI-Device Identifier: 05050474530751
• UDI-Public: (01)05050474530751(17)240222
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 02/22/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 10/25/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/21/2020; 10/30/2020
• 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: 61 YR
• Date Report Sent to FDA: 01/01/2005