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

Model Number ZCT150

Device Problem Unintended Movement (3026)

Patient Problems Visual Disturbances (2140); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is during (b)(6) 019- (b)(6) 2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was explanted from patient's left eye due to iol rotated as well as the power was off, and specific visual issues.The lens was replaced with a model zcu 19.5 diopter lens.No problems with patient post-op.No further information provided.

Manufacturer Narrative

Additional information: section d10: device available for evaluation: yes, returned to manufacturer on 4/8/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the lens was received in a specimen cup.Additionally, documentation was received with scanned images of the original patient stickers.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, a detached haptic, and a cut through the lens (lens not separated), which is consistent with a lens that was handled during explant.Based on the return condition of the lens no further product evaluation could be performed.The reported complaint issue could not be confirmed, and no product deficiency was identified.The reported 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.A search revealed that one complaint for this order number have been received and is not related to the complaint issue reported for this investigation.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, inc.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: 9851738
• MDR Text Key: 188488805
• Report Number: 9614546-2020-00132
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474552128
• UDI-Public: (01)05050474552128(17)220610
• 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: 01/01/2005,11/03/2020

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: 06/10/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• 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: 02/20/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/21/2020; 10/25/2020
• Supplement Dates FDA Received: 04/22/2020; 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention