MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2019 - (b)(6) 2020.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) was explanted from patient's left eye requiring incision enlargement.No suture or vitrectomy were required.Reason for explant was not provided.No further information provided.
Additional Manufacturer Narrative
Additional information received revealed the diagnosis of mechanical failure was the reason for explant.Mechanical failure indicates the patient reports visual symptoms that cannot be resolved.The patient reported symptoms of significant glare with night driving were so disruptive, he did not feel safe driving at night.His occupation requires night driving.The symptoms of glare could not be resolved.The patient was stable when discharged.The replacement lens is a different model and diopter.Visual acuity pre-op (pre-initial implant): 20/25.Visual acuity post-op (post-initial implant): 20/20.Visual acuity post-op (post-replacement):20/20.As a result the following fields have been updated: date of event: (b)(6) 2019.Device available for evaluation, returned to manufacturer on 2/7/2020.(b)(4).Device evaluation: the complaint sample was received with a biohazard specimen bag, a hard copy email, and the complaint lens which was wrapped in gauze.Visual inspection under magnification revealed a bent haptic and debris/fibers on the lens, which may be attributed to the lens being wrapped and returned in gauze, however how and when the haptic was bent and how the debris/fibers were introduced to the lens cannot be confirmed.The lens was then cleaned, and no cosmetic defects were observed.No specific complaint was made against the lens; therefore, no complaint issue could be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaints have been received for 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 and 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 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9697429
• Report Number: 2648035-2020-00128
• Device Sequence Number: 19585064
• Product Code: MFK
• UDI-Device Identifier: 05050474560611
• UDI-Public: (01)05050474560611(17)230520
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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: 05/20/2023
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 10/25/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/13/2020; 11/03/2020
• 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: 67 YR
• Date Report Sent to FDA: 01/01/2005