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

Model Number	ZXT225
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	06/09/2020
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) will be explanted from a post -lasik patient and replaced with a different model and powered lens.Further information was provided and reported that the patient had a refractive error.The lens was explanted from the patient's left eye.There was no vitrectomy, incision enlargement or any other medical or surgical intervention required.There was no patient injury.Another johnson & johnson lens (different model and lower diopter) was implanted as a replacement.The patient states at 1-day post-operative, vision is blurry but better then before.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
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, and that the lens was received cut in half, which is consistent with a lens 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 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 SYMFONY TORIC
• 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: 10774773
• Report Number: 9614546-2020-00470
• Device Sequence Number: 19786882
• Product Code: POE
• UDI-Device Identifier: 05050474605817
• UDI-Public: (01)05050474605817(17)231101
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: 11/01/2023
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: 66 YR