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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypopyon (1913); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional Manufacturer Narrative
Corrected information was provided in h.6.In previous report fda patient code (b)(6) was not captured.
Additional 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
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11838356
• Report Number: 1119421-2021-01043
• Device Sequence Number: 4308438
• Product Code: HQL
• UDI-Device Identifier: 00380655093283
• UDI-Public: 00380655093283
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.245
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/17/2021; 08/09/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 08/09/2021; 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BETADINE SWAB; BSS STERILE IRRIGATING SOLUTION; CENTURION HANDPIECE; CENTURION VISION SYSTEM; CUSTOM SURGICAL PACK; DUOVISC; INDOCOLLYZE; LIDOCAINE GEL; PROVISC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR