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

Model Number ZCT225

Device Problems Dent in Material (2526); Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported upon opening zct225 6.5 diopter intraocular lens (iol) was not in the reservoir of the lens cassette and the lens had scratches and dents.It was also reported outcome does not significantly interferes with activities of daily life and no further information is available.There is no patient contact, no serious patient injury, no medical complications, and there was no surgical intervention.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Additional information: device available for evaluation: yes.Returned to manufacturer on: 07/24/2019.Device returned to manufacturer: yes.Device evaluated by manufacturer: yes.Device evaluation: the product was returned loose within its original box along with the daisy wheel and dfu.The lens was received stuck to the interior surface of the box.A visual inspection of the lens showed paper from the box stuck to the lens surfaces.The lens was cleaned with purified water and dried with compressed air to ease inspection.Minor physical damage in the form of scratches was observed on the optic and the edges of one haptic.The reported cosmetic and lens damaged issues are confirmed, however how and when the damage was introduced could not be determined.Since the lens was received opened, the packaging issue could not be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 8821703
• MDR Text Key: 152057835
• Report Number: 3011852734-2019-00152
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474552463
• UDI-Public: (01)05050474552463(17)211012
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• 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: 06/28/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 07/24/2019; 10/25/2020
• Supplement Dates FDA Received: 08/15/2019; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1