MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS TORIC II IOL; INTRAOCULAR LENS

Model Number ZCU300

Device Problem Difficult to Insert (1316)

Patient Problems Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2022

Event Type  Injury  

Manufacturer Narrative

Unknown/not provided.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.Telephone number: (b)(6).The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) rotation was difficult and the surgeon was unable to place the iol in the desired orientation as the iol did not move at all for the surgeon.This led to zonular dialysis/dehiscence.The lens was fully inserted and removed in the same procedure.A capsular tension ring (ctr) was placed and a 3-piece iol was implanted as a replacement.There was an incision enlargement.There was no delay in treatment and no sutures or vitrectomy required.There was no damage or patient injury.The patient is feeling ok post-operatively.No further information was provided.

Manufacturer Narrative

Section d9: device available for evaluation: yes date returned to manufacturer: oct 6, 2022 section h3: device returned to manufacturer: yes device evaluation: visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, the lens could be observed to be cut however, the cut did not separate the two halves of the lens.No further issues could be identified and no issues that could contribute to or cause positioning issues were identified.The complaint issue ¿dc-positioning issue¿ and was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on complaint investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS TORIC II IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15255753
• MDR Text Key: 298196384
• Report Number: 3012236936-2022-02097
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474693456
• UDI-Public: (01)05050474693456(17)270310
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

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 Model Number: ZCU300
• Device Catalogue Number: ZCU300I180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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