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

Model Number ZCU600

Device Problem Unintended Movement (3026)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2020.If explanted; give date: not applicable, there is no indication the lens has been explanted.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the patient is experiencing blurred vision with model zcu600 intraocular lens (iol) and the lens rotated 35 degrees counter clockwise in the right eye.Visual acuity pre-operative 20/40 and visual acuity post-op 20/400.The lens was planned for an explant.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Additional information: further information was provided and the lens was explanted as planned.The reason for explant was reported as likely due to miscalculation.The lens was replaced with the same model zcu600 10.5 (lower) diopter.No additional information was provided.The following section has been updated accordingly: section d7: if explanted; give date: (b)(6) 2020.Device evaluation: the device was not returned at the manufacturing site; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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 TORIC II 1-PIECE ACRYLIC
• 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: 9795835
• MDR Text Key: 188271216
• Report Number: 9614546-2020-00107
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474665323
• UDI-Public: (01)05050474665323(17)241205
• 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 Model Number: ZCU600
• Device Catalogue Number: ZCU600U130
• Was Device Available for Evaluation?: No
• 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: 02/07/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 03/23/2020; 10/25/2020
• Supplement Dates FDA Received: 04/16/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR