MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60AT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Excessive Tear Production (2235); Discomfort (2330)

Event Date 12/02/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.Information was provided that the lens was implanted on (b)(6) 2017.After a day of treatment on (b)(6) 2017, the patient indicated that the discomfort such as swelling and tearing disappeared, and the condition improved significantly.On (b)(6) 2017, the patient was discharged.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health authority reported corneal edema with discomfort and tearing in an eye one hour following an intraocular lens (iol) implant procedure.At that time, the doctor's treatment was to change to systemic medication and intravenous infusion once a day, to reduce swelling and for anti-inflammation and blood circulation.At the same time, local antibacterial anti-inflammatory was prescribed.After one day of treatment, on the afternoon of (b)(6) 2017, the attending doctor re-examined all the indicators, and the patient said that the discomfort such as swelling and tearing disappeared, and the condition improved significantly.On the morning of (b)(6) 2017, the patient was successfully discharged.Symptoms recovered.The lens remains implanted.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7864657
• MDR Text Key: 119832928
• Report Number: 1119421-2018-01322
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2018

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: 03/31/2022
• Device Model Number: SA60AT
• Device Catalogue Number: SA60ATC225
• Device Lot Number: 12535128
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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