MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT5

Device Problem Entrapment of Device (1212)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The results from the product history record review indicated the product met release criteria.Cartridge product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A surgical technician reported that during an intraocular lens (iol) implant procedure, the iol was tangled with a malyugin ring resulting in a pc tear.Additional information was provided by the initial reporter that the lens was removed through an enlarged incision.There was a vitrectomy and iridotomy performed.The lens was replaced with a different lens model.She also reported that in the surgeon's opinion the iol did not cause/contribute to the event.No further details were provided.

Manufacturer Narrative

Product evaluation: the lens was returned positioned correctly in a #78 (iw) lens case.Solution is dried on the lens.One haptic is broken in the gusset area (not returned).The optic is torn from the edge in toward the optic center, split into portions that are still attached.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a non-qualified cartridge and non-qualified viscoelastic.Cartridge product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The lens diopter is beyond the approved range for use in the cartridge.The root cause of the event may be related to a failure to follow the directions for use.The use of non-qualified products may result in lens delivery difficulties or product damage.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.(b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6485365
• MDR Text Key: 72532967
• Report Number: 1119421-2017-00499
• Device Sequence Number: 1
• Product Code: MJP
• 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: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.260
• Device Lot Number: 12296335
• Other Device ID Number: 00380652251112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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
• Treatment: MALYUGIN RING; MONARCH III D CARTRIDGE; MONARCH III IOL DELIVERY SYSTEM; UNSPECIFIED PROVISC
• Patient Outcome(s): Required Intervention