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

Model Number	ZCT225
Medical Device Problem Code	Unintended Movement (3026)
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, but the best estimate date is during (b)(6) 2017.If explanted, give date: not applicable, remains implanted in the eye.(b)(4).Device evaluation: product testing could not be performed because the product was not returned as it is still implanted.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no similar complaints were received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that patient¿s vision has been bad since surgery in (b)(6) 2017, recently was told by his healthcare provider that he has astigmatism in his left eye when he thought it should have been fixed with the surgery, he can¿t get eye glasses because his prescription keeps changing and is not happy with the lenses.Reportedly he was recommended to use reading glasses.He assumes that his lens may have shifted.Patient is experiencing scattered light, halos, starbursts, double vision especially at night.He can see of about 4 feet away, anything closer is blurry, he can watch television ok, he cannot read a book, he can use his ipad, but needs to zoom all the way in to see it.He really needs glasses, but with his prescription constantly changing he can¿t afford to buy new glasses every time.Additional information was received, and it was learnt that his astigmatism was never resolved, and his daily activities are issue and his night vision is terrible.Patient thinks that his lens in both eyes has rotated due to which he is having this issue.Patient reported that visual acuity issue was right away after the surgery and had become worse after the left eye surgery.This event will capture information for right eye of the patient.A separate report is being submitted for patient¿s left eye.No further information 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: 9619862
• Report Number: 9614546-2020-00031
• Device Sequence Number: 14185028
• Product Code: HQL
• UDI-Device Identifier: 05050474552746
• UDI-Public: (01)05050474552746(17)210508
• 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: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U205
• 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: 12/30/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 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: Other
• Date Report Sent to FDA: 01/01/2005