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

Model Number ZCT600

Device Problem Unintended Movement (3026)

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

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: product evaluation was not performed because per the initial report the lens was discarded by the customer.The complaint issue reported could not be verified and no product deficiency could be 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 of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product 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 tecnis toric intraocular lens (iol) had rotated 24 degrees after one week postop with manifest refraction (mrx) >1.6 spherical equivalent.Patient was 20/20 uncorrected at post-op day 1.At postop week 1, her vision was 20/100.The surgeon planned on rotation only, but the patient was -1.5 so the surgeon decided on a lens exchange with a lower diopter.However, the ocular response analyzer (ora) stated to use the same diopter 16.0 again.The patient also experienced blurry vision.The lens was explanted and replaced with the same model and diopter.The explanted lens was discarded.No additional information provided.

• 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
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; lot h.s (d) 70252, pt 2489; jalan hi tech 11, industrial z; kulim hi tech park 09000 ; MY 09000
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10933213
• MDR Text Key: 219126371
• Report Number: 2020664-2020-00056
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474604087
• UDI-Public: (01)05050474604087(17)221026
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2022
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR