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	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate is during (b)(6) 2019.If implanted, give date: unknown, information not provided.(b)(4).Device evaluation: the product was not returned to the manufacturing site; therefore, product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no additional complaint was received from this production order.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zlb00 22.0 diopter intraocular lens (iol) was explanted because the patient complained that the visual quality was not as good as their fellow eye which has a symfony lens implanted.The lens was exchanged for a zxt150 21.5 diopter lens in a secondary surgery.No incision enlargement was required.The patient is okay and in good health post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Additional info: based on receiving new information, if implanted: give date: (b)(6) 2019 has been updated accordingly.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(b)(4).

• 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: 8689562
• Report Number: 2648035-2019-00632
• Device Sequence Number: 3030398
• Product Code: POE
• UDI-Device Identifier: 05050474560710
• UDI-Public: (01)05050474560710(17)221014
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 10/14/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0220
• 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: 05/15/2019
• Supplement Date Received by Manufacturer: 06/21/2019; 10/25/2020
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 06/21/2019; 11/12/2020
• 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