MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC II 1-PIECE ACRYLIC; TORIC IOLS

Model Number ZCU225

Device Problem Unintended Movement (3026)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

If explanted, give date: not applicable, as lens remains implanted.Device evaluation: product evaluation cannot be performed as per the initial report, the lens remains implanted.The complaint issue reported could not be verified, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.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

Report of the study patient's operative visit stated that the actual intraocular lens (iol) axis placement was 176 degrees for the left eye (os).The patient's slit lamp axis measurement os at 1 day post-operative visit was recorded as 006 degrees.This is a 10 degree rotation of the iol as compared to the axis placement.The patient's 1 week os, post-operative visit slit lamp axis measurement was recorded as 006 degrees again.Uncorrected visual acuity os at the 1-day postoperative visit: 20/16.Subject reported no visual symptoms at this visit.No surgical intervention is planned at this time.No other information was provided.

Manufacturer Narrative

Additional information: the complaint was based upon a subjective estimate made by the investigator from a slit-lamp measurement.For this study, we have also been doing independent analysis of the intraocular lens (iol) photos taken at each visit.These are objective measurements of the actual iol axis.Based on this objective measurement, the actual amount of iol rotation for the subject below is less than 03 degrees.There is still no surgical intervention planned.The subject has one more study visit left to complete (3-month study visit).Subject visit schedule page study eye delta angle from base: 80819504009 po 1 day - second eye analyst 1 review os 0.369; 80819504009 po 1 day - second eye analyst 2 review os 2.441.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS TORIC II 1-PIECE ACRYLIC
• 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: 11049520
• MDR Text Key: 223187458
• Report Number: 9614546-2020-00526
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474659001
• UDI-Public: (01)05050474659001(17)241218
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR