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

Model Number ZCB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown, best estimate is between (b)(6) 2019 - (b)(6) 2019.(b)(4).Device evaluation: the product was returned within a plastic sample jar.A visual inspection of the returned lens show that it was cut in half, most probably to aid in explant.Traces of ophthalmic viscosurgical device (ovd) and blood were visible on the surfaces of the lens.The lens was cleaned with purified water and dried with compressed air to ease inspection.Under magnification, cosmetic damage to the surfaces of the lens could be seen.How and when these damaged were introduced cannot be determined, however the condition of the lens is consistent with one that has been cut and removed from the eye.The lens would have been rejected if these damages were observed during manufacturing.Based on the condition of the lens, further analysis is not possible.The reported complaint event cannot 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 production 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.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.The device was manufactured at the (b)(4) site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported zcb00 23.0 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2018.The zcb00 23.0 diopter lens was explanted on (b)(6) 2019 due to complaints of blurry vision / impaired vision.It was reported there was no incision enlargement, no suture(s), no vitrectomy, and patient outcome was reported as good.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.No additional information was provided to johnson & johnson surgical vision.

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 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9533658
• MDR Text Key: 185710472
• Report Number: 2020664-2019-00021
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531772
• UDI-Public: (01)05050474531772(17)220419
• 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: 01/01/2005,11/04/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• 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: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention