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

Model Number PCB00

Device Problem Scratched Material (3020)

Patient Problems Corneal Edema (1791); Eye Pain (4467)

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4 and a5: age, date of birth, weight, ethnicity and race: unknown/not provided.Section d6b: explant date: na as the lens remains implanted.Section e1: email address: unknown/not provided.Section e1: telephone number: (b)(6).Section h3-other (81): 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 and complaint history for production order 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.

Event Description

It was reported there were cracks observed on the preloaded monofocal intraocular lens (iol) and they were only observed in the optical part of the iol after being pushed out.One of the cracks was closest to the center of the optical part.The lens was not removed due to the patient's high sensitivity to pain.The patient had mild edema before surgery.After surgery, the patient's vision was 0.3.It was hard to determine the extent of the crack's impact on patient's vision.Based on the additional information received, edema reported is corneal edema and patient gradually recovered from it by the time of discharge.The pain reported is eye pain.There was no delay in treatment or other interventions performed.Patient has made a fair postoperative recovery.No further information was provided.

• 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: 18376802
• MDR Text Key: 331383579
• Report Number: 3012236936-2023-03206
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558274
• UDI-Public: (01)05050474558274(17)250828
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2022
• 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