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

Model Number ZCT525

Device Problem Unintended Movement (3026)

Patient Problems Unspecified Infection (1930); Blurred Vision (2137); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date not provided, only that repositioning was conducted about two weeks from date of implant.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 one additional investigation (ir), this ir was a duplicate of the complaint sn; therefore, this ir was cancelled.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 Description

A female patient reported issue with her implants.She indicated that a topography was not used by her doctor when she had lens implants and that they both rotated off the correct axis.The patient had macular pucker and a vitrectomy in the (b)(6) 2018 which as the patient put it, it may have been caused by weak zonules.When the left eye was implanted on (b)(6) 2019, the patient noticed a diagonal line in her vision and when informed her doctor, she was told that the lens had rotated off its axis.The left eye¿s lens rotation and repositioning occurred about 2 weeks from the date it was implanted.Patient indicated that when the lens was rotated back, it caused a wrinkle in the capsule on (b)(6) 2019.The right eye that was implanted on (b)(6) 2019 also rotated, but no repositioning was done on this eye.No information about the degree of rotation was provided to the patient.The patient experienced hemorrhaging and an infection and was told that they caused scar tissues.The patient had yttrium-aluminum garnet (yag) posterior capsulotomy laser procedure done on both eyes in (b)(6) 2020 due to opacity in the right eye and to help with the wrinkled capsule in the left eye.The patient¿s visual acuity was 2500 due to the material remaining in her eye after the cataract surgery which also changed her eye color.The patient was given vancomycin injection as well as vancomycin, tobramycin and prednisolone eye drops for the right eye to resolve those issues.The patient reported that vitreous material left behind on the lenses caused scar tissues.The patient noted that after yag, things were brighter, but the treatment did not resolve the ghosting issue which she would see on the top of what she would be looking at.According to the patient everything has a shadow which makes writing look mushed together.The doctor told the patient that the eyes are competing to see and it makes everything look smushed.The patient¿s night vision is like before she had cataract surgery done.Reportedly, glasses and contacts did not fix the patient¿s problem.The patient was told by other specialist and retina specialist that the lens is tilted, rotated and since so much has been done on her eyes including yag that they cannot go in to rotate the lenses.The patient was also told that it is not easy to explant/replace the lenses.The patient now has distorted vision, gets headaches when watching tv for a while, cannot read or sew.The patient can drive, but cannot see signs unless she is right up on the sign.The patient uses a +2.5 regular readers but the vision is still distorted.The patient had bilateral lenses implanted.This mdr report pertains to the patient's right eye.A separate report is being submitted for the patient's left eye.

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10893246
• MDR Text Key: 219527318
• Report Number: 9614546-2020-00498
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474603509
• UDI-Public: (01)05050474603509(17)210115
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U165
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention