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	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zlb00 intraocular lens (iol) was implanted in the patient's right (od) eye on (b)(6) 2019.It was later explanted on (b)(6) 2020 due to patient intolerance of the multifocal lens.The replacement lens is a zcu150.At exchange, there was no incision enlargement and no injury reported.The current patient status was reported as doing ok.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 3/31/2020.Device evaluation: the product was received in a plastic bag identified with patient stickers for the complaint and replacement lens.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was returned cut in half, which is consistent with a lens that was handled during explant.Furthermore, marking holes were observed on the lens, which identifies this lens as a toric lens and not a multifocal lens as described in the initial report.Several follow up attempts have been made to address this issue, although no information has been received.If additional information is received after initial closure, the ir and compliant file can be re-opened to complete the return investigation.Based on the return condition of the lens, no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.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.
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-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: 9919219
• Report Number: 2648035-2020-00318
• Device Sequence Number: 16968056
• Product Code: MFK
• UDI-Device Identifier: 05050474560529
• UDI-Public: (01)05050474560529(17)221130
• 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): 10/30/2020
• 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: 11/30/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/04/2020; 10/25/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/04/2020; 10/30/2020
• 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