MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.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) using a preloaded delivery system the lens appeared to come out abnormally, in a non-fluid way.There was no reported patient involvement.Additional information was requested.

Manufacturer Narrative

The device was not returned.Only the lens was returned and the opened blister tray inside the opened carton.The lens was returned adhered to adhesive tape on the well area of a the lens case base.Solution and a spot of what appears to be blood was dried on the lens.One haptic distal tip is adhered in solution to the anterior optic surface.No damage observed to the optic.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the complaint of "lens coming out abnormally".It is not possible to confirm how the lens advanced beyond the device tip or if the lens was in a proper position during delivery because the lens was returned outside the device.The device was not returned to evaluate.The returned lens was cleaned to remove the dried viscoelastic and further assess.The dimensional plan view inspection indicated that the lens met specification per the approved template.A fold test was conducted.The lens folded and unfolded with no abnormalities observed.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 9901378
• MDR Text Key: 186823163
• Report Number: 1119421-2020-00541
• Device Sequence Number: 1
• Product Code: KYB
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12731249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1