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

Model Number	ZXT150
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	08/24/2020
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 a zxt150 model intraocular lens (iol) was explanted from patient's right eye in a secondary surgical procedure because the lens was implanted upside down.Doctor had noticed that lens flipped upside down while inserting lens into the eye and it was noticed during post op that patient vision was negatively impacted.There was no patient injury and no medical/surgical interventions such as vitrectomy, incision enlargement or sutures were required.The replacement lens used is a same model and diopter lens.The patient was doing fine at the time of discharge.Additional information was received stating that there were no visual symptoms experienced by the patient.No further information was provided.
Additional Manufacturer Narrative
Section d10: device available for evaluation? yes.Returned to manufacturer on: 10/12/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received inside a specimen cup.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptic and that the lens was received cut in half (only one half received), which is consistent with a lens that was handled during explant.The lens was cleaned, and dimensional inspection was performed on the single haptic and measured within specifications.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 and released according to specification.The search 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 product quality deficiency.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: 10659373
• Report Number: 9614546-2020-00448
• Device Sequence Number: 11549845
• Product Code: POE
• UDI-Device Identifier: 05050474605220
• UDI-Public: (01)05050474605220(17)220922
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 11/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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: 74 YR