MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON IOL, UNSPECIFIED

Model Number ASKU

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Blurred Vision (2137)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.(b)(4).

Event Description

A health authority reported that two days following a cataract extraction with an intraocular lens (iol) implant procedure, the patient developed lens displacement.The patient experienced poor, blurry vision.

• Brand Name: IOL, UNSPECIFIED
• Type of Device: UNK
• 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 ; 33 journey; suite #175; aliso viejo, CA 92658 ; 8176152230
• MDR Report Key: 7864989
• MDR Text Key: 120107721
• Report Number: 1119421-2018-01328
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• 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
• 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