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

Model Number ICB00

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

Patient Problems Corneal Abrasion (1789); Inflammation (1932)

Event Type  Injury  

Event Description

It was reported that a patient had inflammation cyclitic membrane and corneal striae 1-week post implantation with an intraocular lens (iol) in the patient's right eye.The vision dropped by two (2) lines (vision post-operative: 6/9 to 6/18).The patient was given medications.There was no delay in treatment and no other interventions reported.No other information was provided.

Manufacturer Narrative

Weight: unknown/not provided.Ethnicity: unknown/not provided.Date of event: unknown, not provided, but the best estimate date is (b)(6) 2022, 1-week post-operation.If explanted, give date: not applicable, as the device remains implanted.Initial reporter first & last name: information unknown/not provided.Initial reporter telephone number: (b)(6).The device was not returned for evaluation as it remains implanted; 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.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.

• Brand Name: TECNIS 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: 14341787
• MDR Text Key: 294679702
• Report Number: 3012236936-2022-01220
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474610767
• UDI-Public: (01)05050474610767(17)260930
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICB00
• Device Catalogue Number: ICB00I0205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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 Sex: Male