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

Model Number ZCT150

Device Problem Unintended Movement (3026)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: the complaint lens was received submerged in an unknown solution inside a specimen cup.Additionally, a shipping label was received as well.Visual inspection under magnification revealed a detached haptic and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Dimensional inspection was performed (haptic width and haptic thickness on the remaining haptic), and all measurements were within specifications.Based on the return condition of the lens no further evaluation could be performed.The complaint issue could not be confirmed, 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

It was reported that an intraocular lens (iol) rotated 30 degrees and was noted to manifest as decreased visual acuity.Therefore, the iol was explanted from the patient¿s right eye.It was replaced with a different model iol, 21.5 diopter power.There was no incision enlargement, no vitrectomy, or no sutures required.There was no patient injury post-op.No other information was provided.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• 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: 10377035
• MDR Text Key: 202010565
• Report Number: 9614546-2020-00293
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474552180
• UDI-Public: (01)05050474552180(17)200503
• 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: 01/01/2005,10/29/2020

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: 05/03/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR