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

Model Number AU00T0

Device Problems Failure to Fold (1255); Stretched (1601); Material Twisted/Bent (2981)

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

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported the intraocular lens (iol) in a preloaded delivery system had a stretched haptic, was twisted, and did not fold as desired.There was no patient contact and a backup lens was implanted without issue.Additional information was requested.

Manufacturer Narrative

The device with the lens was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger is at the trailing optic edge.The lens is advanced to mid-nozzle.The trailing haptic is folded in on the optic.The leading haptic is extended.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was observed.No problems are observed with the returned device.The plunger, lens and haptic positions are acceptable.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the dfu.A straight leading haptic may occur: due to the normal folding variations as indicated in the dfu diagrams.If the initial plunger advancement is faster than the recommended target, the leading haptic may be forced past the internal folding feature.If the ovd fill rate is too fast the folding effect on the leading haptic is minimized.If there is excessive delay between the device preparation and subsequent delivery the leading haptic may start to unfold.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement or contribute to incorrect haptic folding.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional clarification received reports the stretched haptic was the leading haptic.

• 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: 8524764
• MDR Text Key: 142472656
• Report Number: 1119421-2019-00489
• 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,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12577827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 07/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC