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

Model Number AU00T0

Device Problems Material Deformation (2976); Ejection Problem (4009)

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

Event Date 01/14/2020

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 facility representative reported that during a cataract extraction with an intraocular lens (iol) implantation, the "lens kinked up and would not eject".The reported stated "believes the cartridge or loader may have touched the eye.Lens would not come out of loader though", the procedure was completed.Additional information was requested.

Manufacturer Narrative

Additional information was provided in h.3., h.6.And h.10.Evaluation summary: the device with the lens was returned in a biohazard bag.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been advanced to mid-nozzle and has overrode the lens.The lens has been advanced partially into the nozzle area.Half of the lens is still located within the loading area.The trailing haptic is folded onto the optic along the left side of the plunger.The leading haptic is in an extended position located under the plunger.The nozzle was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.A qualified viscoelastic was used.A plunger override was observed.This may have been interpreted as the reported complaint of ¿lens kinked up and would not eject¿.The root cause cannot be determined.The lens is partially still within the loading area.The observation of a plunger override while the lens was still partially within the lens loading area may indicate that the delivery rate was faster.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided by the surgical technician, who reported that there was no patient harm.No additional intervention was required.

Manufacturer Narrative

Corrected information was received and provided in b.3.Corrected and additional information was provided in a.1., a.2., a.3., b.5.And d.11.Additional information was provided in d.10., h.3., h.6.And h.10.Evaluation summary: the product was returned for analysis.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).

• 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: 9683965
• MDR Text Key: 182720590
• Report Number: 1119421-2020-00201
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12744785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DUOVISC VISCOELASTIC
• Patient Age: 69 YR