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

Model Number AU00T0

Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597); Physical Resistance (2578)

Patient Problem Corneal Edema (1791)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and the 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.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.There are no other complaints in the lot.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during the injection of an intraocular lens (iol) there was resistance with the plunger.A haptic was stuck and damaged; therefore the lens was removed from the eye and another lens was implanted.The patient encountered corneal edema postoperatively, which was treated with eye drops and it resolved.The patient was noted to be recovered.Additional information was requested.

Manufacturer Narrative

The device and the lens were returned separated.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.Two broken haptics pieces are side by side in the plunger groove.The bottom of the nozzle tip has an aneurysm.The rest of the lens was returned in the bottom of the blister tray.Viscoelastic is dried on the lens.One haptic is broken-gusset area.The lens is cracked in the haptic insertion area of the other haptic.Viscoelastic was not provided.It is unknown if a qualified product was used.The device was returned and damage was observed to the nozzle tip.Two broken pieces of haptic were also observed in the plunger groove.The plunger was retracted.The root cause for the reported stuck haptic cannot be determined.The plunger position in relation to the broken haptic during advancement cannot be determined.However, the damage to the nozzle tip would indicate the plunger/lens were not in acceptable positions for advancement.This most likely was the cause of the reported resistance.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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 7434973
• MDR Text Key: 105633336
• Report Number: 1119421-2018-00421
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: AU00T0
• Device Lot Number: 12516415
• Other Device ID Number: 00380652358330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR