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 Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: product testing could not be performed because the product was not returned as the iol was disposed.A product quality deficiency could not be confirmed.The reported issue was not verified.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 kulim site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).The iol was explanted due to complaints of lens rotation.The incision was enlarged.There was no suture(s) and no vitrectomy.The lens was disposed and is not being returned.Through follow-up, additional information was received confirming the lens rotated 13 degrees and patient reported blurry vision.A jjsv lens with different model and diopter size was implanted.Patient outcome was reported as vision doing ok adjusting with some irritation.No further information was 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: 10694670
• MDR Text Key: 211890374
• Report Number: 2020664-2020-00052
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474553361
• UDI-Public: (01)05050474553361(17)211019
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2020

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: 10/19/2021
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• 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: 70 YR