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

Model Number ZCU225

Device Problem Break (1069)

Patient Problems Vitrectomy (2643); No Code Available (3191)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).Device evaluation: the complaint lens was received stuck on the label of its original lens case.The original folding carton and directions for use (dfu) were received as well.Visual inspection under magnification revealed what appeared to be dried blood and viscoelastic residue on the optic body and haptics, and that the lens was received cut in half, which is consistent with a lens that was handled during removal and replacement.White fibers/debris were observed on the lens, which can be attributed to receiving the lens stuck to the white label of the lens case.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was fully inserted into the patient's right eye but was noticed to be scratched.Therefore, the lens was removed and replaced with a different model za9003 19.5 diopter iol.Vitrectomy and sutures were required.No other 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 nr-0148919 and capa-010215.

• 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: 10467469
• MDR Text Key: 204874383
• Report Number: 9614546-2020-00344
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474658998
• UDI-Public: (01)05050474658998(17)241206
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• 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

• Date FDA Received: 08/28/2020
• 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: ZCU225U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR