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	Corneal Edema (1791); Endophthalmitis (1835); Inflammation (1932); Blurred Vision (2137); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that four days following a cataract extraction with intraocular lens (iol) implant procedure, the patient developed conjunctival inflammation, corneal edema, aqueous cell, pain and decreased vision.There was no aqueous fibrin and no hypopyon.The patient was diagnosed with sterile endophthalmitis.Post operation steroids and antibiotics were prescribed to the patient.A tap/injection of antibiotics was performed.There was no growth from the cultures.There are three medical device reports associated with this facility.This report is the second of three reports.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received, stating as per surgeon's opinion.None of the company products caused or contributed to the event.
Additional Manufacturer Narrative
Correction: on initial mdr the patient code of 4581 was reported in error.Corrected information provided in h.10.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 12540104
• Report Number: 1119421-2021-01839
• Device Sequence Number: 4584703
• Product Code: HQL
• UDI-Device Identifier: 00380655093122
• UDI-Public: 00380655093122
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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 Expiration Date: 03/21/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.165
• Device Lot Number: 15170256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 11/02/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/28/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BETADINE DROP 0.5%; BETADINE SKIN PREP; BSS STERILE IRRIGATING SOLUTION; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; CORTEF/FORTAZ; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC VISCOELASTIC SYSTEM; OMIDRIA 1% ADD TO 500 ML; PHACO TIP; BETADINE DROP 0.5%; BETADINE SKIN PREP; BSS STERILE IRRIGATING SOLUTION; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; CORTEF/FORTAZ; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC VISCOELASTIC SYSTEM; OMIDRIA 1% ADD TO 500 ML; PHACO TIP
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Male