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

Model Number ZCT400

Device Problem Unintended Movement (3026)

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

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that lens was explanted from patient¿s left eye in secondary surgical procedure because of patient experiencing mechanical complication, unpredictable refraction outcome with lens rotation and blurry vision.There was no incision enlargement, no sutures and no vitrectomy required.Visual acuity pre-operative was 20/60 and visual acuity post-operative was 20/25.A different model lens with a higher diopter was used as the replacement lens for the patient.Patient was satisfied with outcome.No further information provided.

Manufacturer Narrative

Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 3/31/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the lens was received cut in pieces, 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.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.No other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.H3 other text : placeholder.

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) 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: 9927482
• MDR Text Key: 192011874
• Report Number: 9614546-2020-00172
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474553996
• UDI-Public: (01)05050474553996(17)200224
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/30/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2020
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• 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: 03/10/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 04/12/2020; 10/25/2020
• Supplement Dates FDA Received: 04/29/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR