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

Model Number AU00T0

Device Problem Torn Material (3024)

Patient Problem Shock (2072)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.A root cause has not been identified.(b)(4).

Event Description

A doctor of ophthalmology reported that during injection of the lens during an intraocular lens (iol) implant procedure, it felt like there was a "shock" and the implant of the preloaded delivery system entered the bag more quickly and the bag was torn.It was hence not possible to implant the iol.The physician does not know if this is due to the preloaded system or not.The lens was replaced.Additional information has been requested but not received to date.

Manufacturer Narrative

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

Event Description

Additional information was received, indicating that the retina of the patient was detached later on as a consequence of the event.The patient, who is an independent welder, had to suspend his professional activities for four months.

Manufacturer Narrative

Product evaluation: the device was not returned.Only half of the lens was returned taped to the outside of the carton.The lens appears to have been cut in half typical of a removal.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause for the reported event cannot be determined.The device was not returned for evaluation.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds (ophthalmic viscosurgical devices) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.(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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6982654
• MDR Text Key: 90426664
• Report Number: 1119421-2017-01241
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.250
• Device Lot Number: 12452432
• Other Device ID Number: 00380652358378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2016
• 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: 65 YR