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 Bacterial Infection (1735); Endophthalmitis (1835); Loss of Vision (2139); Vitrectomy (2643)

Event Date 11/05/2018

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 physician reported following an intraocular lens (iol) implant procedure, the patient experienced a sudden drop in vision for one day.The patient was hospitalized on the 6th postoperative day and was diagnosed with endophthalmitis.A vitrectomy+ intra-ball injection + anterior chamber irrigation and fascia capsule injection were performed.The operation was smooth, postoperative local anti-inflammatory, anti-infective and other symptomatic treatment.The whole body is treated with anti-infection, nutritional nerves, and improved circulation.The aqueous humor was cultured for 72 hours, and the growth of the vitreous juice of the vitreous cavity was carried out before perfusion.After the perfusion, a small amount of staphylococcus epidermidis grew in the vitreous humor.The patient was discharged approximately 3 weeks later and was given non-steroidal eye drops, antibiotic eye drops, steroid/antibiotic eye drops, ointment and an antibiotic ophthalmic gel.Supplemental tablets were also given.

• 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: 8786242
• MDR Text Key: 150877866
• Report Number: 1119421-2019-01113
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2019

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 Expiration Date: 02/28/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WFC225
• Device Lot Number: 12601728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR