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

Model Number	ZCU300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that at the study patient's operative visit the actual intraocular (iol) axis placement was 174 degrees for the first operative left eye (os).The patient's slit lamp axis measurement at the first eye os 1 day post-operative visit was recorded as 001 degrees.The patient's 1 week first eye, os, post-operative visit slit lamp axis measurement was recorded as 004 degrees.This is a 10 degree rotation of the iol as compared to the axis placement.It was noted that the uncorrected visual acuity os at the 1-week postoperative visit: 20/25.Manifest refraction: 0.00 +0.75 x13.Best-corrected distance visual acuity: 20/25.Subject reported no visual symptoms at this visit.No surgical intervention is planned at this time.No other information was provided.
Additional 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 02 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.80819504011 po 1 week - first eye analyst 1 review os 1.988.80819504011 po 1 week - first eye analyst 2 review os 0.753.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS TORIC II 1-PIECE ACRYLIC
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.HQL; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11049638
• Report Number: 9614546-2020-00527
• Device Sequence Number: 2691761
• Product Code: MJP
• UDI-Device Identifier: 05050474660175
• UDI-Public: (01)05050474660175(17)241209
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2024
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR