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

Model Number AU00T0

Device Problems Break (1069); Scratched Material (3020)

Patient Problem No Code Available (3191)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Additional information has been requested but not received to date.

Event Description

A doctor of ophthalmology reported that during an intraocular lens (iol) implant surgery, the plunger damaged the optical part of the lens making a large scratch on the optic.The cartridge was filled from the tip up to the mark with viscoelastic as required, lens was pushed forward properly and in compliance with the time intervals and implanted.Lens had to be removed and substituted for a different one that was implanted manually.Incision had to be sealed at the end of the surgery with a single corneal suture.Additional information has been requested but not received to date.

Manufacturer Narrative

Evaluation summary: the root cause may be related to a failure to follow the directions for use (dfu).As stated in the intraocular lens with the preloaded delivery system involved dfu, only two qualified viscoelastics must be used in conjunction with the device.All other viscoelastics, including the one reported by customer, are not qualified for use.Lens delivery performance may be negatively affected when using a non-qualified viscoelastic leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the dfu for the intraocular lens with preloaded delivery system used and is not recommended under any circumstance.

Manufacturer Narrative

(b)(4).

• 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: 5229325
• MDR Text Key: 31360047
• Report Number: 1119421-2015-06604
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• 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: AU00T0.220
• Device Lot Number: 12387051
• Other Device ID Number: 00380652358316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 71 YR