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 Corneal Edema (1791); Endophthalmitis (1835); Inflammation (1932); Blurred Vision (2137); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/24/2021

Event Type  Injury  

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 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.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received, stating as per surgeon's opinion.None of the company products caused or contributed to the event.

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
• Type of Device: 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
• MDR Text Key: 273566127
• Report Number: 1119421-2021-01839
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093122
• UDI-Public: 00380655093122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 10/01/2021; 11/02/2021
• Supplement Dates FDA Received: 10/28/2021; 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Male