MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC 1-PIECE; MONFOCAL

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Date of Event	01/09/2019
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 an intraocular lens (iol) was explanted from the patient's operative eye.Through follow-up, it was learned patient had vision correction enhancement on (b)(6) 2019.The lens was explanted as the patient had a poor visual outcome.There was no vitrectomy, incision enlargement or sutures required.Another johnson & johnson lens (same model and lower diopter) was successfully implanted as a replacement.The patient was discharged in good condition.No additional information was provided.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 10/21/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the complaint lens was received in a specimen cup.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens handled during explant.The lens was cleaned, and no cosmetic defects were observed.The complaint issue could not be confirmed and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS TORIC 1-PIECE
• Common Device Name: MONFOCAL
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10564640
• Report Number: 9614546-2020-00423
• Device Sequence Number: 2842891
• Product Code: HQL
• UDI-Device Identifier: 05050474552098
• UDI-Public: (01)05050474552098(17)210330
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 03/30/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: 72 YR