MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

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

Patient Problems Hypopyon (1913); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that following an intraocular lens (iol) implantation procedure, a patient experienced toxic anterior segment syndrome (tass).Hypopyon was present during the postoperative visit.The patient was treated with a combined antibiotic-corticosteroid ophthalmic medication every hour.The patient's symptoms have resolved.This report is for patient 3 (intraocular lens).

Manufacturer Narrative

Corrected information was provided in h.6.In previous report fda patient code (b)(6) was not captured.

Manufacturer Narrative

The product was not returned for analysis.Not enough information was provided from the account for further investigation.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11838356
• MDR Text Key: 251150851
• Report Number: 1119421-2021-01043
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093283
• UDI-Public: 00380655093283
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.245
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BETADINE SWAB; BSS STERILE IRRIGATING SOLUTION; CENTURION HANDPIECE; CENTURION VISION SYSTEM; CUSTOM SURGICAL PACK; DUOVISC; INDOCOLLYZE; LIDOCAINE GEL; PROVISC
• Patient Outcome(s): Other
• Patient Age: 54 YR