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 Conjunctivitis (1784); Corneal Edema (1791); Purulent Discharge (1812); Endophthalmitis (1835); Erythema (1840); Unspecified Infection (1930); Irritation (1941); Burning Sensation (2146)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that 10 days following an intraocular lens (iol) implant procedure, a patient developed signs of an infection and was treated with an intravitreal antibiotic injection.Three days later, the va was 20/60-1 and continues with aggressive antibiotic therapy.Additional information was provided by a nurse, who indicated that the patient experienced constant burning, red, irritated, lid mattering, 1+ corneal edema, 2-3 mucal purulent discharge, 1+ descemet folds, 4+a/c cells, 3+ conjunctival inflammation, and hypopyon.The surgeon is unsure what caused or contributed to the event.The diagnosis is endophthalmitis.

• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8404238
• MDR Text Key: 138253609
• Report Number: 1119421-2019-00274
• Device Sequence Number: 1
• Product Code: HQL
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.195
• Device Lot Number: 12649126
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALCAINE; BALANCE SALT SOLUTION; BROMSITE P/O; CEFUROXIME 1MG INTRACAMERALLY; CENTURION PHACO HANDPIECE; CUSTOM EYE PAK; DISCOVISC; DUREZOL GTTS P/O; FMS WITH INTREPID ULTRA SLEEVES; INTREPID 0.3 POLYMER IA TIP; LIDO JELLY PREOP; POVIDONE IODINE 10%
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR