MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS MULTIFOCAL TORIC II IOL; TORIC IOLS

Model Number	ZKU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: date of event: exact date is unknown, information not provided.Best estimate is between 08/06/2020 - 11/19/2020.Patient code: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Customer reported the intraocular lens (iol) was explanted due to the patient experiencing dysphotopsia.There was no vitrectomy, sutures, or incision enlargement.The explanted lens was replaced with a model#: zma00 lens with the same diopter.The patient outcome is fine.Per the customer, no further information is available.
Additional Manufacturer Narrative
Correction: section e1: initial reporter.The doctors name was initially reported as (b)(6) but should have been (b)(6).Additional information: section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 01/06/2021.Section h3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received wrapped in gauze.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics.The lens was returned cut in half with lens damage, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, 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 specifications.A search revealed that no similar complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS MULTIFOCAL TORIC II IOL
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11052683
• Report Number: 9614546-2020-00530
• Device Sequence Number: 14116256
• Product Code: MJP
• UDI-Device Identifier: 05050474688100
• UDI-Public: (01)05050474688100(17)250415
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 04/15/2025
• Device Model Number: ZKU300
• Device Catalogue Number: ZKU300U155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/19/2021
• 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