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 Vitreous Floaters (1866); Inflammation (1932); Eye Infections (4466)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

Explant date: not applicable, as lens was not explanted.(b)(6).The intraocular lens (iol) is not returning 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, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the patient complained of floaters in right eye with an intraocular lens (iol) 2 days after surgery.On examination, patient had anterior and posterior segment inflammation( ac cells 3+, vitritis 2+).The patient was given intravit antibiotics on same day and started on oral steroids and antibiotics after ruling fungal infection.Post injection was given and there was decrease in inflammation.Patient is under close observation while on oral steroids and frequent topical steroid antibiotic combination.Patient daily activities significantly affected.Sutures were required.Vision pre-operative: 6/60, vision post-operative: 6/18.No further information available.

• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12724832
• MDR Text Key: 279909683
• Report Number: 2020664-2021-07921
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474610750
• UDI-Public: (01)05050474610750(17)241022
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• 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: 10/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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