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

Model Number	ZCT400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is from (b)(6) 2019 to present.If explanted, give date: not applicable, as the lens remains implanted.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that 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 and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
A female patient reported that she had double vision in both eyes.However, after the surgery it enabled her to have double vision in one eye (left eye).The patient confirmed that the problem is only with her left eye.The surgery has improved her vision; however, the patient still cannot see.The patient indicated that she has a very bad astigmatism and has always had night blindness.But after the surgery, the issue is twice as bad, and she has zero depth perception which is why she no longer drives at night.When the patient looks at a traffic light, she sees another traffic light just below it.The lights and starburst bother the patient very much, but she has been using a special mirror device just for driving which has been helping her with the lights.The patient reported that she cannot read a road sign until she is about to pass it.She is inverting numbers, and when she looks in the mirror her pupils are different sizes.The pupil in the left eye is larger than the pupil in the right eye.The patient also had floaters which are gone for the most part.The patient corrected herself that she never had any pain as was initially reported, but just an unusual feeling.The patient confirmed that she was not given any medication out of the normal treatment regimen, and there was no complication during the surgery.No additional information was 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 (b)(4) and capa-010215.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10136675
• Report Number: 9614546-2020-00218
• Device Sequence Number: 2094691
• Product Code: HQL
• UDI-Device Identifier: 05050474553804
• UDI-Public: (01)05050474553804(17)220425
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• 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: 04/25/2022
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U145
• 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: 05/15/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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