MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Positioning Problem (3009)

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

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported an intraocular lens (iol) in a preloaded delivery system is faulty.Additional information was requested.

Manufacturer Narrative

Additional information provided in d.11., h.3., h.6., and h.10.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the dfu.A non-qualified viscoelastic was used in the device.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the company intraocular lens with the company preloaded delivery system dfu, only qualified viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the dfu for the company intraocular lens with the company preloaded delivery system and is not recommended under any circumstance.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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: 9901251
• MDR Text Key: 186752669
• Report Number: 1119421-2020-00539
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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: ACU0T0
• Device Lot Number: 12735636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: Z-HYALINE.