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

Model Number ZCT150

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

Catalog #: a complete catalog number is unknown since device serial number was not provided expiration date: unknown, as the serial number was not provided.Serial number: unknown, information not provided.Udi #: a complete udi # is unknown as product serial number was not provided.If implanted; give date: unknown/not provided.If explanted, give date: not applicable, the lens remains implanted to date.Phone number: (b)(6).(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: manufacturing record review cannot be performed since the serial number is unknown.A search of complaints related to serial number cannot be performed since the serial number is unknown.Conclusion: no sample was returned and the serial number is unknown an investigation could not be performed, and no malfunction is confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The account reported of an intraocular lens (iol) rotation.1st day post-op: the lens axis is positioned to 160 degree.1st week post-op: lens axis rotated anti clockwise to 180 degree.The doctor repositioned the lens one week after the first operation.The iol rotated by 20 degree (180 - 160 degree), but it rotated anticlockwise the same way again.It was indicated that the doctor will not reposition the lens again for now.No further information was provided.This mdr report captures the first rotation and repositioning of the lens.A separate mdr will be submitted for the second rotation.

Manufacturer Narrative

Corrected data: in review, it was noted that the codes (4109 & 3331) were entered in the section ''h6-method codes'' which should have not been used.Also, it was noted that inadvertently the code (213) was entered in the section ''h6-result codes'' of the initial mdr report which is incorrect.The information has corrected in this mdr supplement and the following field was updated accordingly: 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: 10788385
• MDR Text Key: 214757767
• Report Number: 2648035-2020-00813
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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: 11/10/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention