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

Model Number ZCU225

Device Problem Unintended Movement (3026)

Patient Problems Dry Eye(s) (1814); Therapeutic Effects, Unexpected (2099); Blurred Vision (2137)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

If explanted; give date: n/a (not applicable).The lens remains implanted.Device evaluation: the device was not returned at the manufacturing site as it remains implanted; 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 other 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.

Event Description

It was reported that the patient has a post operative (op) refraction +1.50-.50x75 with an intraocular lens (iol).Eye exam using snellen chart: os 20/30 -1 ph: 20/20.Auto refraction: os +1.00 -0.25 x 055.Manifest refraction: os +1.50 -0.50 x 075 add +2.50 dcc: 20/20 ncc: j1+.Patient reports in the left eye, things are not as clear as they were right after surgery.The patient is using eye drops to help with dryness, but that has not made any changes to the vision.Additional information was reported that the iol rotated 10 degrees.Iol axis placement: 177, pre-op best corrected visual acuity (bcva): 20/40.At a 3-month visit ((b)(6) 2020), iol axis placement: 180, bcva os: 20/20+2.In an unscheduled visit on (b)(6) 2020, patient complained of blurry vision.Uncorrected visual acuity (ucdva) os: 20/30, bcdva os: 20/20, and iol axis placement: 170 (10 degrees from last measured at 3 month visit).At this time, there are no plans for intervention.No additional information was provided.

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 (b)(4).

• 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: 10446144
• MDR Text Key: 209405895
• Report Number: 9614546-2020-00331
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474658882
• UDI-Public: (01)05050474658882(17)241122
• 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: 01/01/2005,10/29/2020

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: ZCU225
• Device Catalogue Number: ZCU225U155
• 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: 07/30/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR