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

Model Number	Z9002
Medical Device Problem Codes	Difficult to Insert (1316); Defective Component (2292)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/ date of birth: unknown/ not provided.Sex/ gender: unknown/ not provided.If implanted, give date: not applicable, there is no indication the lens was implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.Attempts have been made to obtain missing information; however, no definitive 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 an intraocular lens (iol) had a haptic so big the surgeon could not get it positioned.The capsule tore and a vitrectomy was required, however, it was not product related.There was no indication of patient injury, or any other medical or surgical intervention required.The patient is doing fine post-operatively.No additional information was provided to johnson & johnson surgical vision.
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.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 8/18/2020 section h3: device returned to manufacturer ¿ yes.Device evaluation: the lens was evaluated under microscope and was observed cut and have residues of viscoelastic.The condition observed is consistent with a lens that has been explanted.Due to the condition in which the lens returned, the reported issue could not be verified.As the lens returned cut and handled, a product quality deficiency or product malfunction could not be determined.The complaint issue could not be verified to be associated to manufacturing process.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that 1 other complaint has been received for this production order number and this complaint meets the criteria for no further investigation per johnson & johnson surgical vision complaint handling procedures.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 10318333
• Report Number: 2648035-2020-00549
• Device Sequence Number: 17015319
• Product Code: HQL
• UDI-Device Identifier: 05050474530669
• UDI-Public: (01)05050474530669(17)231023
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 10/23/2023
• Device Model Number: Z9002
• Device Catalogue Number: Z900200185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/27/2020; 10/25/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/23/2020; 10/29/2020
• 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