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

Model Number	ZXT150
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate is between 10/15/2020 and 11/18/2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis symfony intraocular lens (iol) was explanted from the patient's right (od) eye due to mechanical failure.There was no additional surgical intervention required and patient outcome was not reported.No further information was available.
Additional Manufacturer Narrative
Section d10: device available for evaluation? yes; section d10: returned to manufacturer on: 1/6/2021; section h3: device returned to manufacturer? yes.Device evaluation: the product was returned wrapped in gauze.Customer notes (on a post-it) and additional documentation were received as well.Visual inspection under magnification, revealed viscoelastic residue on the optic body and haptics.And that the lens was received cut in half (but not separated).Which is consistent with a lens that was handled, during explant.Furthermore, fibers were observed on the lens.However, this can be attributed to receiving the lens wrapped in gauze.And therefore, cannot be confirmed, to be related to manufacturing.The lens was cleaned, and no cosmetic defects were observed, due to the condition of the lens (cut).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 specification.Historical data analysis: a search of complaints revealed, no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product 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 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: 11024089
• Report Number: 9614546-2020-00521
• Device Sequence Number: 16310474
• Product Code: POE
• UDI-Device Identifier: 05050474605282
• UDI-Public: (01)05050474605282(17)211130
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 02/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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