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 Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that one additional complaint was 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from patient's left eye as the patient was unhappy.The vision was blurry at 1 day post-op and was experiencing sub-optimal vision at distance and mid-near.Patient's activities were tremendously affected and was experiencing difficulty with watching tv, reading up close and working on computer.Patient was using multiple reading glasses to help for all focal lengths due to hyperopic outcome.No other surgery or medical intervention was required and no suture was placed.No other rx was given other than normal post-op drops.The replacement lens used is a same model but different diopter lens.Patient was doing very well at the time of discharge.Patient/ user outcome: pre-op visual acuity w/ glasses 20/25, visual acuity with tmf ( implanted on (b)(6) 2019) 20/50, reading j7 @22'''', visual acuity with tmf iol exchange on (b)(6) 2020, 20/20, reading j1 @16''''.No other information provided.
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: 10112173
• Report Number: 9614546-2020-00210
• Device Sequence Number: 17098057
• Product Code: MFK
• UDI-Device Identifier: 05050474560642
• UDI-Public: (01)05050474560642(17)230405
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 04/05/2023
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 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: 71 YR
• Date Report Sent to FDA: 01/01/2005