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

Model Number AAB00

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

Patient Problem Visual Disturbances (2140)

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced a retinal tear while visiting jordan on (b)(6)2023.The treatment involved removing the natural lens, laser surgery and intraocular lens (iol) implantation, which all occurred in jordan.The patient reported that the doctor used silicon oil to tamped off the retinal tear.The patient's vision was fine until on (b)(6) 2023.While back in the united states, a follow up treatment was required.This involved a vitrectomy and the removal of the silicon oil since at this time the patient was experiencing a lot of floaters and cloudiness.No further information was provided.

Manufacturer Narrative

Section d6b - explant date: not applicable, lens remains implanted.Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR 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: 18927360
• MDR Text Key: 337944548
• Report Number: 3012236936-2024-00675
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474548688
• UDI-Public: (01)05050474548688(17)260609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male