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

Model Number AU00T0

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Eye Injury (1845); No Code Available (3191)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.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 physician reported that during an intraocular lens (iol) implant procedure, while injecting the lens there was a patient injury.Additional information was provided by the surgeon that the surgery was proceeding normally.When the iol was injected, it seemed to be moving through the cartridge smoothly as expected for a higher power iol (27.0).It seems the trailing haptic was tucked behind the optic in the cartridge which is a problem that is seen fairly often but this time as the trailing haptic/optic junction went through the end of the cartridge, it seems that there was kind of a release of pressure on the part that was hung up and the iol shot forward very quickly and right through the posterior capsule, leaving very large post capsular tear and the iol was immediately lost into the vitreous cavity.The iol was not advancing quickly at all but slowly and smoothly and possibly the poorly loaded cartridge caused the iol to get hung up and then spring forward.The patient was left with iol in vitreous cavity, vitreous loss, no second functional iol was placed that day.The patient had to be sent to retina surgeon to remove iol from vitreous and new iol sutured in.

Event Description

Additional information was provided that the patient is currently in a retina surgeon's care and the prognosis is unknown.

Manufacturer Narrative

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: 10474594
• MDR Text Key: 205091911
• Report Number: 1119421-2020-01207
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12569398
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PROVISC OVD
• Patient Outcome(s): Other
• Patient Age: 68 YR