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

Model Number ZCT150

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.(b)(6).Device evaluation: the product was received at the manufacturing site for evaluation in a lens holder.The lens was inspected using a 12x magnification.It can be seen that the lens is contaminated.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.There is a scratch on the optic and the edge of the optic is damaged.Investigation of the return sample and the condition of the return sample do not suggest that scratch and damage is produced during manufacturing.The complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specifications.The search in the complaint system revealed that no similar complaints were 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 complaint could not be verified.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that the surgeon found the haptic loop of intraocular lens, model zct150 already deformed when he opened the package, so he did not use it.There was no patient contact reported and it was indicated that the device was available for evaluation.No additional information was provided.

Manufacturer Narrative

Additional information received for the investigation clarification indicated that the inspection of the haptics resulted in no anomalies found.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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: 9173901
• MDR Text Key: 199093287
• Report Number: 9614546-2019-00960
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474538146
• UDI-Public: (01)05050474538146(17)230409
• 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,Followup
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2023
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT1500190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1