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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.Device evaluation: product testing could not be performed because the product was not returned.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A patient reported that a model zlb00 intraocular lens (iol) was implanted in his left eye, and he was happy with it although there was very minimal glare and halo which was expected.Slightly amblyopic in that eye so expectation was not high.However, almost a month later he was implanted a zxr00 iol in his right eye.Over time the patient claimed to have a few glare and halos, but they are minimal and at this point not at all an issue.Yet, he remained very happy with his left eye.His night vision was as expected pretty poor to begin with.As time went on his daylight vision became superb.He is far less dependent on readers than he had been pre-op.Also, beginning right after surgery he had significant issue with bright lights at night (e.G.Car lights, street lights, any sort of spot type light).He sees clearly defined spider webs 100% of the time when presented with described light conditions.He rarely drives in non-daylight hours.As he approached the one-year anniversary he became concerned that he will be stuck with this condition unless he has the lens removed and replaced with another lens.As he is amblyopic, he does not want the risk of any sort of retinal complication on his dominate eye with a second surgery.As his day vision is superb and his multifocal eye is doing well, he is convinced the issue is not the surgeon but rather something specific to the symfony lens.No other information was provided.
Additional Manufacturer Narrative
Additional information: the patient has halos and glare initially but he noted them as minimal and not an issue.Upon further follow-up, it was learned that the patient is still experiencing them.The dysphotopsia he described as almost going blind because of the lens.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
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-0148919 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: 9447151
• Report Number: 9614546-2019-01096
• Device Sequence Number: 2093881
• Product Code: POE
• UDI-Device Identifier: 05050474579071
• UDI-Public: (01)05050474579071(17)211118
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 11/18/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0190
• 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: 11/12/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 10/25/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/18/2020; 11/05/2020
• 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: Other
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005