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

Model Number ZCT100

Device Problem Unintended Movement (3026)

Patient Problems Visual Impairment (2138); No Consequences Or Impact To Patient (2199); Zonular Dehiscence (2698); No Code Available (3191)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/not provided.If explanted; give date: the lens remains implanted.Device evaluation: the device was not returned at the manufacturing site; 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 similar complaint for this production order number has been received.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.

Event Description

It was reported that an intraocular lens (iol) was implanted and the lens rotated while surgeon was closing the wounds.Surgeon went back and rotated it into position.At post operative, the lens had again rotated.The lens is still implanted.Through follow-up, it was learned both lens rotations (same lens and same patient) were observed immediately postoperative on the same day of the surgery approximately one hour from the surgery time.The surgeon tried to re-rotate it back the first time and it rotated again on the surgery date.The lens rotated about 30 degrees each time.The lens was rotated back into position.No other treatment was provided.The patient outcome on (b)(6) 2020, visual acuity (va) on the operative eye is 20/70 and pinhole occlude (ph) 20/40.The lens remains implanted.No other information was provided.

Manufacturer Narrative

Further information was provided, and the lens was explanted.The lens was replaced with a new diopter.No further information was provided.The following section has been updated accordingly: section h6: patient code of 3191- explant of lens.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.

Manufacturer Narrative

Additional info: further information was provided and reported the white to white (wtw) measurement in the right eye is 12.7 mm.Astigmatism on ar: 0.75/ astigmatism on iol master: 0.56 and astigmatism on pentacam: 0.8.No other information was provided.Attempts have been made for further clarification; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional info: further information was provided and reported, the lens rotates freely, due to a larger capsule.The lens was 30 degrees off again.The patient had significant amount of astigmatism.The capsule bag collapsed a little bit (b)(6) months out.Therefore, the lens will be re-rotated, once more to see if it stays stable.If not, a photo refractive keratectomy (prk) laser will be performed to fix the residual astigmatism.No other information was provided.The following section has been updated accordingly: section h6: patient code 2138; section h6: patient code 2698.An attempt has 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.

• 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: 10961084
• MDR Text Key: 234035370
• Report Number: 2648035-2020-00913
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474537514
• UDI-Public: (01)05050474537514(17)240121
• 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,Followup,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: ZCT100
• Device Catalogue Number: ZCT1000170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention