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

Model Number ZCT300

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/not provided.Sex/gender: unknown/not provided.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Expiration date: unknown, as the serial number was not provided.Serial number: unknown, as information was not provided.Udi number: unknown, as the serial number was not provided.If implanted; give date: unknown/not provided.If explanted; give date: not applicable, there is no indication the lens has been explanted.Device manufacture date: unknown, as the serial number was not provided.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) had a 40 degree rotation.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Additional info: further information was provided, the lens rotation was observed post-operatively (op).The iol was repositioned in the left eye.The lens was noted to be at repositioned axis at postop follow up 1 week out.No further information was provided.The following section has been updated accordingly: section a2: age/date of birth: (b)(6) 1949 section a3: sex/gender: male section b1: updated to both adverse event and product problem section b2: outcomes attributed to adverse event: required intervention section d4: catalog number: zct300u225 section d4: expiration date: 11/20/2022 section d4: serial number: (b)(4) section d4: udi number: (b)(4) section d6: if implanted; give date: (b)(4) 2020 section h4: device manufacture date: 11/20/2018 device evaluation: the device was not returned at the manufacturing site as it remains implanted; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaints have been received for this production order number.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.

• 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: 10544784
• MDR Text Key: 207311317
• Report Number: 2648035-2020-00690
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

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 Expiration Date: 11/20/2022
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR