MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number AU00T0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/18/2020

Event Type  malfunction  

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 health professional reported that during an intraocular lens (iol) implant surgery, the lens was faulty.Additional information has been requested.

Manufacturer Narrative

The product was returned for analysis and plunger override was observed.Additional observations were as follows: the device was returned in the blister tray inside the carton.The lens stop and the plunger stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been advanced into the mid nozzle and is advanced over the lens.The lens is advanced into the nozzle entry.The leading haptic is extended straight.The trailing haptic is folded and is located on the left side of the plunger with the distal portion facing the nozzle tip.The correct nozzle confirmed on the device.We are unable to determine the root cause for the reported complaint.Plunger override was observed.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 10385369
• MDR Text Key: 203159598
• Report Number: 9612169-2020-00170
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: AU00T0
• Device Lot Number: 21244629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PROVISC.