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 Problem Uveitis (2122)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It was reported that after seven (07) days post intraocular lens (iol) implantation, patient developed iritis in their right eye.Medication of apdrops dm & t+ was prescribed.There was no incision enlargement, no vitrectomy and no sutures done.The patient's daily activities are not significantly affected.The iol remains implanted.No further information available.

Manufacturer Narrative

Patient information cannot be provided due to personal data privacy legislation/policy explant date: not applicable, as lens remains implanted.Email address: unknown/not provided, as information was asked but 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: upon further review of the file it was noted that the prescribed medication indicated in the initial report was incorrect.The correct prescription should have been provided as follows in the event description: section b5: describe event or problem: medication of cyclomid & predmet was prescribed.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: 15196234
• MDR Text Key: 297572021
• Report Number: 3012236936-2022-02136
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474610750
• UDI-Public: (01)05050474610750(17)261003
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• 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: ICB00I0200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2021
• 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