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

Model Number ZCT300

Device Problem Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, information not provided.If explanted, give date: not applicable due to lens has not been explanted.Device evaluation: product testing could not be performed as the lens remains implanted, the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for 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.Note: the device was manufactured at the kulim site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a zct300 22.5 diopter intraocular lens (iol) likely rotated greater than 10 degrees and has causing the patient to experience blurry vision.The doctor plans on explanting the iol.No further information was provided.

Manufacturer Narrative

Additional information: section d10: device available for evaluation, yes.Section d10: returned to manufacturer on, 03/16/2019.Section h3: device returned to manufacturer: yes.With the return of the device explant of the device the planned explant has taken place, therefore section b2 is now updated to required intervention, and patient code 3191-explant is being entered.Section b2: required intervention to prevent permanent impairment/damage.Section h6: patient code 3191 - explant.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye revealed viscoelastic residue on the optic body and haptics, and that the lens was received cut in half, 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.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.

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: 9815674
• MDR Text Key: 188804478
• Report Number: 2020664-2020-00020
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474553378
• UDI-Public: (01)05050474553378(17)210703
• 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,Followup
• Report Date: 01/01/2005,11/02/2020

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: 07/03/2017
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• 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: 02/11/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 03/19/2020; 10/25/2020
• Supplement Dates FDA Received: 03/20/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention