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

Model Number ZCT400

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional information: date of event: unknown as information was not provided.The best estimate date is between (b)(6) 2019 and (b)(6) 2020.(b)(4).Device evaluation: the lens was received in a specimen cup.Visual inspection with the unaided eye revealed viscoelastic residue on the optic body, and that the lens was received cut in pieces (with pieces of the lens and both haptics missing), which is consistent with a lens that was handled during explant.Based on the return condition of the lens no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.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.Note: the device was manufactured at the (b)(6) site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported zct400 21.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) (per patient implant card information) on (b)(6) 2019.The zct400 lens was explanted on (b)(6) 2020 due to rotation, and it was determined that a different diopter was needed for the desired result.The zct400 lens replaced with another zct400 but higher diopter (23.0)lens.It was reported outcome does not significantly inter with activities of daily life and the patient has recovered.There is no further information available.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
• 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: 9858659
• MDR Text Key: 188806142
• Report Number: 2020664-2020-00025
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474553941
• UDI-Public: (01)05050474553941(17)210830
• 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
• Report Date: 01/01/2005,10/30/2020

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: 08/30/2021
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• 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: 02/21/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention