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

Model Number AU00T0

Device Problems Positioning Failure (1158); Scratched Material (3020)

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

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

Product history records were reviewed and documentation indicated the product met release criteria.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.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A customer reported an intraocular lens (iol) in a preloaded delivery system did not unload correctly and the lens was scratched.Additional information was requested.

Manufacturer Narrative

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

Event Description

Additional information was received clarifying that the technicians load the lenses prior to the procedure.The surgeon will inspect the lenses under a microscope.If the surgeon does not like the way the lens looks or questions it, the facility reports that lens as "scratched".It is unknown at this time if the lens was scratched or if the surgeon was questioning the lens.

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 non-qualified viscoelastic was indicated.The returned device does not match the reported events.The lens has not been delivered and no lens damage was observed.No problems are observed with the returned device.The plunger, lens and haptic positions are acceptable.A straight leading haptic is observed.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the directions for use (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 viscoelastic 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 viscoelastics 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 customer indicated a non-qualified viscoelastic was used.Material properties of non-qualified viscoelastics may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the 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 and is not recommended under any circumstance.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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7942964
• MDR Text Key: 123210433
• Report Number: 1119421-2018-01454
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12567414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR