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

Model Number ZCT150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Iritis (1940); Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2020 - (b)(6) 2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens was explanted from patient left eye due to residual astigmatism and decreased visual acuity.At lens exchange, there was no incision enlargement, no vitrectomy, or suture required.The explanted lens was replaced with a different model, zct225 and higher diopter (22.0).Iritis was noted after implant of the initial lens, and prescription was given by the doctor outside of normal post-operative routine by increasing frequency of pred forte.Visual acuity pre-op (pre-initial implant): 20/100.Visual acuity post-op (post-initial implant): 20/50.Visual acuity post-op (post-replacement): 20/50.No further information provided.

Manufacturer Narrative

Device evaluation: product evaluation cannot be performed as the product was discarded.The complaint issue reported could not be verified 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 in complaint system 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 verified.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: 11023777
• MDR Text Key: 222002664
• Report Number: 9614546-2020-00520
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474538184
• UDI-Public: (01)05050474538184(17)230207
• 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: 01/29/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2023
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT1500210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention