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	Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown as information was not provided.The best estimate date is between (b)(6) 2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zlb00 21.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2019.The zlb00 21.5 diopter lens was explanted on (b)(6) 2019 due to goal of plano was not met, result was +1.00 with complaints of glare and halos.The patient was not able to tolerate, and outcome significantly interfered with activities of daily life.The zlb00 21.5 diopter lens was replaced with a model za9003 22.5 diopter lens.It was reported the patient has recovered and no further information is available.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on: 02/17/2020.Device evaluation: the lens was received in the replacement lens¿ daisy wheel.Visual inspection under magnification revealed the lens to be cut in half, which is consistent with a lens that was handled during explant.Additionally, viscoelastic residue was observed on the optic body and haptics.Based on the return condition of the lens, no further evaluation could be performed.The complaint issue could not be verified, 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 of complaints revealed that one (01) additional investigation request (ir) for this production order number has been received; however, the complaint issue reported could not be confirmed.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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: 9690191
• Report Number: 2648035-2020-00119
• Device Sequence Number: 11545461
• Product Code: MFK
• UDI-Device Identifier: 05050474560703
• UDI-Public: (01)05050474560703(17)230210
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: distributor,health profession
• 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: 02/10/2023
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/21/2020; 10/25/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/17/2020; 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
• Date Report Sent to FDA: 01/01/2005