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

Model Number AU00T0

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

A sample is in transit to manufacturing site.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.Additional information has been requested but not received to date.(b)(4).

Event Description

A doctor of ophthalmology reported that a lens broke into pieces during an intraocular lens (iol) implant.Additional information was received.Once the lens was in the anterior chamber, the haptic broke.The edge of the lens was damaged too.The lens was removed from the eye and another lens was implanted.The event caused a 1-1.10 hour delay and an important loss of endothelial cells.According to the reporter, the event was caused by the plunger.Additional information has been requested but not received to date.

Manufacturer Narrative

Evaluation summary: the complete device was not returned.A portion of the lens was returned in solution inside a bss 15ml bottle.The optic portion was torn/split with a broken haptic.Product history records were reviewed and the documentation indicated the product met release criteria.Two viscoelastics were indicated, only one is qualified for this device.It is unknown if the approved component of the indicated viscoelastic was used.The product investigation could not identify a root cause because the device was not completely returned for evaluation.It is unknown if a qualified viscoelastic was used.As stated in the directions for use (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 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.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5261312
• MDR Text Key: 32524816
• Report Number: 1119421-2015-06724
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.240
• Device Lot Number: 12384562
• Other Device ID Number: 00380652358354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2015
• 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 Outcome(s): Other