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

Model Number SA60AT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Edema (1791); Pain (1994); Swelling (2091)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: 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.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 that one hour after an intraocular lens (iol) implant procedure, the patient experienced eye pain and weeping.The diagnosis was confirmed to be corneal edema.Temporary treatment was changed to systemic medication: sodium chloride, steroid injections, antibacterial and anti-inflammatory eye drops, intravenous infusion once a day to reduce swelling for anti-inflammatory treatment.After a day of treatment, the patient said that the eye swelling and tearing had disappeared.The medical condition significantly improved.Two days later, the patient's symptoms disappeared and the indicators were normal.The patient was discharge on that day.No further information is expected.

• 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: 7865860
• MDR Text Key: 119867259
• Report Number: 1119421-2018-01336
• 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

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: SA60AT
• Device Catalogue Number: SA60ATC125
• Device Lot Number: 12380153
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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): Required Intervention