MAUDE Adverse Event Report: JJSV MFG. MALAYSIA SDN. BHD. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.The device was manufactured at the (b)(4) site which has been closed.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 due to refractive surprise due to halos and glares.Another johnson & johnson zcb00 lens (different model and same diopter) was implanted as a replacement.There was no incision enlargement, no vitrectomy, no sutures required.There was no patient injury.Patient is doing good post-operatively.Suspect product was discarded.No other information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): JJSV MFG. MALAYSIA SDN. BHD.; ind. zone phase 3, kulim hi-te; kulim, kedah 09000 ; MY 09000
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12829320
• Report Number: 2020664-2021-07939
• Device Sequence Number: 17285992
• Product Code: MFK
• UDI-Device Identifier: 05050474560635
• UDI-Public: (01)05050474560635(17)220708
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 07/08/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White