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

Model Number ASKU

Device Problems Structural Problem (2506); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation root cause has not been identified.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported during the implant of an intraocular lens (iol) the leading haptic came out straight and the junction of the haptic/optic was torn.The lens remains implanted and there is no reported patient impact.Additional information was requested.

• Brand Name: IOL, UNSPECIFIED
• Type of Device: UNK
• 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: 8707470
• MDR Text Key: 148941426
• Report Number: 1119421-2019-00935
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/18/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/18/2019
• 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