MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number AU00T0

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

Patient Problems Hypopyon (1913); Inflammation (1932); Uveitis (2122); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure.Upon examination of the patient, the surgeon noted aqueous cell, aqueous fibrin, hypopyon, conjunctival inflammation.The patient was prescribed with post-operative antibiotic, steroid and non-steroidal anti-inflammatory drugs.No cultures were performed.The patient's symptoms have been resolving with topical medication.This is the first of three reports for this event.

Manufacturer Narrative

The product was not returned for analysis.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.There have been no other complaints for this lot.Investigation has been completed based on current information.No further action is warranted at this time.Based on our trend analysis, there are no adverse trends identified for this complaint and based on these findings the residual risk remains at an acceptable level the manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13722844
• MDR Text Key: 286959352
• Report Number: 9612169-2022-00107
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652394673
• UDI-Public: 00380652394673
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: AU00T0
• Device Lot Number: 21274418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INDOCOLLYNE 3 DAYS; ISO[UNREADABLE HANDWRITING[ OPHTHA; LIDOCAINE; MYDRIOSERT; OXYTAPROCAINE 3X; POVIDONE IODINE 10%; TOBRADEX; UNSPECIFIED BSS; UNSPECIFIED CPAK
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Sex: Female