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

Model Number ZCT300

Device Problem Unintended Movement (3026)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If explanted, give date: not applicable, remains implanted in the eye.Device evaluation: product evaluation cannot be performed as per the initial report, the lens remains implanted.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaints have been received for this po.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 & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that patient complained about poor vision.Doctor noticed that lens has rotated significantly during post-op week one, will have to reschedule another surgery day to realign lens in right axis.Direction for use was followed.Lens remains implanted and patient is temporarily impaired.No vitrectomy or no medication was prescribed.Issue is affecting activities of daily life significantly.Vision post-operative: 20/40 dv.No further information provided.

Manufacturer Narrative

Additional information was received from follow-up stating that there was four degrees of rotation and also the lens has been repositioned respectievly.As per additional information the following fields were updated: section h6: patient code- reposition rotationally.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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
• MDR Report Key: 10840883
• MDR Text Key: 217650831
• Report Number: 2648035-2020-00853
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474539433
• UDI-Public: (01)05050474539433(17)231007
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT3000245
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention