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

Model Number	ZXR00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2019 - (b)(6) 2019.(b)(4).Device evaluation: the lens was observed cut in two pieces, that could be related to the explant process.Lubricant material residues and loose particles can be observed on the lens surface.Both haptics looks in good conditions.As the reported issue is unspecified and no additional details was provided there is no issue to verified.Based in the analysis product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that one additional complaint was received from this production order for cosmetic and no indication of a product malfunction was identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.An attempt has been made to obtain missing information; however, no definitive response has been received.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 left eye due to a mechanical failure.There was no vitrectomy, incision enlargement or sutures required.There was no patient injury.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: device available for evaluation, returned to manufacturer on: 12/16/2019.Through follow-up the date of event was provided.Therefore, section 'event date' previously reported as (b)(6) 2019 is now been updated accordingly.It was also learned that the patient experienced light sensitivity.The replacement lens was a different model but same diopter.The patient is still experiencing blurred vision.Best corrects to 20/20 vision and is using eye drops.No additional information was provided.The following sections have been updated accordingly: date of event: (b)(6) 2019.(b)(4).Device evaluation: the received lens was observed cut in two pieces, that could be related to the explant process.Lubricant material residue and loose particles can be observed on the lens surface.Both haptics look in good condition.There was no issue against the lens quality.No product quality deficiency was reported.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints revealed one other complaint was received under this production order; however, there was no indication of a product malfunction.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.
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 (b)(4) and capa(b)(4).

• 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: 9491856
• Report Number: 2648035-2019-01354
• Device Sequence Number: 2079690
• Product Code: POE
• UDI-Device Identifier: 05050474579132
• UDI-Public: (01)05050474579132(17)230621
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 10/25/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/10/2020; 11/04/2020
• 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: 66 YR
• Date Report Sent to FDA: 01/01/2005