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

Model Number Z9002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Retinal Detachment (2047)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation: the product was returned to the manufacturing site for evaluation.The complaint lens was received inside of a specimen cup.Visual inspection under magnification revealed that the complaint lens was received cut in half, in a way that did not sever the lens.One haptic was observed detached, the other was observed to be bent.The lens was cleaned, and no further issues were identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed one additional investigation request (ir) for this production order number has been received, however, complaint issues reported were not related; therefore, no escalations are required.Conclusion: the reported complaint issue 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.Attempts have been made to obtain missing information; however, no definitive response has been received.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 right eye due to silicone oil.Another lens of different model and diopter was used as the replacement.No other surgical interventions were required.Additional information received revealed that there was retinal detachment and the lens was explanted along with residual silicone oil.Post-explant, the patient was healing well with elevated intraocular pressure observed on day 1 post-operation that improved with decompression.No other information was provided.

• Brand Name: TECNIS CL 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: 15687001
• MDR Text Key: 302561739
• Report Number: 3012236936-2022-02692
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530416
• UDI-Public: (01)05050474530416(17)210909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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: 66 YR
• Patient Sex: Male