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

Model Number	ZXR00
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2019.Device evaluation: product testing could not be performed because the product was not returned.The reported complaint was not confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.The search revealed that no similar complaints were received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that patient had symfony non-toric implanted after the cataract surgery on (b)(6) 2019.Reportedly the surgery went uneventful and next day the visual acuity was 20/20.10 days later, when the doctor was getting ready to perform second eye, patient reported that she was terrible distance vision, however her near vision is great.Lens was in perfect position, eye totally quiet.No viscoelastic behind the lens or anything else affecting the position.Patient was 20/80 sc (without correction) and j1.Refraction was between -.50, -.75 20/20.Surgeon was supposedly going to wait 3-4 weeks and if the issues were not resolved a lens exchange was a probability.Additional information was received, and it was learnt that tecnis symfony multifocal intraocular lens (model zxr00 +23.5 diopter) was explanted from patient¿s operative eye because of patient experiencing poor vision.There was no incision enlargement, no vitrectomy and no sutures required during the explant procedure.Reportedly lens with same model and lower diopter of 22.5 was used as replacement for the patient.Patient was doing well.No further information provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-(b)(4) and capa-010215.

• Brand Name: TECNIS SYMFONY
• 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: 8845185
• Report Number: 9614546-2019-00676
• Device Sequence Number: 290334
• Product Code: POE
• UDI-Device Identifier: 05050474579163
• UDI-Public: (01)05050474579163(17)221127
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020
• Report Date (Section F): 01/01/2005

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: 11/27/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 11/13/2020
• 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
• Date Report Sent to FDA: 01/01/2005