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 Code	No Code Available (3191)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/ date of birth: unknown, information not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model z9002 intraocular lens (iol) was explanted from patient's operative eye in a secondary surgical procedure on the same day as indicated in the source document because wrong lens was used.Current patient status is patient has recovered and outcome does not interfere with activities of daily life.No further information is available.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 3/10/2020.Device evaluation: the complaint product was received on march 10, 2020.It was returned in a plastic bag with the daisy wheel case.The lens was observed cut into pieces which could be related to the explant process.Based in the information provided, the lens was explanted because wrong lens was used.The reported issue is not a device problem.There is no product quality deficiency identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.There was no discrepancy and/or deviation found during the mrr (manufacturing record review).The search revealed no additional complaints were received from this production order.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
During review of the reported event on 06/12/2020, it was determined that implant date of the intraocular lens is (b)(6) 2020 based on the implant notification card.The lens was explanted on a different day and not the same day as initially reported.As a result, the following field has been updated: if implanted, give date: (b)(6) 2020.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: 9770975
• Report Number: 2648035-2020-00196
• Device Sequence Number: 19563497
• Product Code: HQL
• UDI-Device Identifier: 05050474530805
• UDI-Public: (01)05050474530805(17)240529
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/02/2020
• 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: 05/29/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 06/12/2020; 10/25/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/17/2020; 06/24/2020; 11/02/2020
• 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
• Date Report Sent to FDA: 01/01/2005