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	Pain (1994); Visual Impairment (2138); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date is between 9/25/2018 to 1/22/2020.If explanted, give date: not applicable, as the lens remains implanted to date.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A report was received from a male patient who had intraocular lenses implanted in both eyes one (1) year ago.He reports that vision in the left eye (os) is poor and his eye hurts.The patient also experiences discomfort, that after a few hours of working on the computer, he feels an ache in the back of his eyes and must use a patch over the eye after a few hours.The patient indicated that he is using eye drops for lubrication but it does not help.Reportedly, the poor near vision is most noticeable.The patient was referred to a different doctor for a second opinion and was told he has astigmatism.The patient was supposed to have vision corrected to 20/25, but the second opinion reported 20/40.The patient thinks he should have had a toric monofocal lens instead of the multifocal tecnis symfony which he currently has implanted in his left eye.The patient uses glasses which he did not want to wear in the first place, uses computer and does his daily activities but reportedly, he ends up with aches and pain.The patient feels that the doctor put in a lens that was not compatible with astigmatism which he thinks he had this condition before the surgery.The patient had the right eye cataract surgery done after being told it would correct the issues he was having, which according to the patient, it has not.The patient wishes to have this lens explanted for exchange with another model.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned (the lens remains implanted).The reported complaint was not confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no similar 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 and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision 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 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: 9723279
• Report Number: 9614546-2020-00067
• Device Sequence Number: 329630
• Product Code: POE
• UDI-Device Identifier: 05050474591752
• UDI-Public: (01)05050474591752(17)230215
• 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): 11/02/2020
• 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: 02/15/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0155
• 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: 01/22/2020
• Supplement Date Received by Manufacturer: 02/28/2020; 10/25/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/26/2020; 11/02/2020
• 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
• Date Report Sent to FDA: 01/01/2005