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	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed / replaced during the same procedure.If explanted, give date: not applicable, as lens was removed / replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a z9002 intraocular lens (iol) was inserted but doctor saw the capsule bag got damaged.The lens was removed.It was noted that there was vitrectomy and sutures were placed.The doctor put in the lens and then took it out.There was capsule tear; but was unconfirmed if that was the doctor's reason for removal.The same model lens was used for the replacement.Patient was well post-op.No other information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation, returned to manufacturer on: 10/1/2019.Device evaluation: the returned sample was received.Only returned folding carton box and lens case/insert.However, in the initial report there was no specific report against the suspect lens.Therefore, the reported event cannot be verified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed no additional investigation requests for this production order number.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.
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 nr-0148919 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: 9121151
• Report Number: 2648035-2019-01043
• Device Sequence Number: 2347135
• Product Code: HQL
• UDI-Device Identifier: 05050474530874
• UDI-Public: (01)05050474530874(17)211031
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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,Followup
• Report Date (Section B): 11/09/2020
• 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: 10/31/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 10/25/2020
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/06/2019; 11/10/2020
• 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: 74 YR
• Date Report Sent to FDA: 01/01/2005