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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2017 and (b)(6) 2019.If explanted, give date: not applicable, as lens remains implanted.(b)(4).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 confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the patient that since his cataract surgery in his right eye in (b)(6) of 2017, he has been seeing starbursts and ''coronas'' (sometimes multicolor), on head lights and street lights.The lens implanted was a zct225 17.0 the patient claimed that he sees well for distance.The patient said that he was treated with drops/etc.For his dry eye and it made no difference.He stated when he attends a hockey game and looks out on the ice he sees the bright light of the ice rink and then it blocks his ability to see the letters/ads on the side boards.The patient stated that he told his doctor that he does not want to do his 2nd eye until the issue with this eye is resolved.It was learnt in follow-up that after the implant about 2 years ago, the patient¿s vision improved to 20/20 (?) but in time, he developed a haze.He told his doctor about it and his doctor said that the haze could be from scar tissue that developed from post-op, so about 1 year after, the patient underwent laser surgery.The haze disappeared but the issues that he mentioned initially such as starbursts and coronas (sometimes multicolor), on head lights and street lights started to appear.He was referred to different doctors and all of whom said that they find nothing wrong and they do not know why patient is still having the visual issues.The patient is unhappy.The patient claims that the visual issues significantly interfere with his regular activities.He said that he kept on going back to his doctor who says that everything looks good, there is no plan to remove the lens, but his visual issues never disappear or improve.No other 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 nr-0148919 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: 8814788
• Report Number: 9614546-2019-00637
• Device Sequence Number: 11564576
• Product Code: HQL
• UDI-Device Identifier: 05050474552678
• UDI-Public: (01)05050474552678(17)200420
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• 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: 04/20/2020
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U170
• 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: 06/24/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/23/2019
• 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: Other
• Date Report Sent to FDA: 01/01/2005