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

Model Number SN6AT8

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/21/2015

Event Type  Injury  

Event Description

A doctor reported a broken haptic was discovered before an intraocular lens (iol) implant procedure.Following extraction of the cataract, the assistant discovered the haptic of the iol was broken when opened.The iol was discarded and an aspheric lens was used instead of a toric lens as previously planned.Additional information was requested.

Manufacturer Narrative

Product evaluation: product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Manufacturer Narrative

Additional information provided.Product evaluation: the returned sample was evaluated.The damage appears indicative of lens case related damage.Results from the product history record review indicated the product met release criteria.Due to the absence of clinical solution on the returned sample, the root cause is potentially manufacturing related.If the lens becomes misaligned in the lens case while closing, lens damage may occur.

• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4866950
• MDR Text Key: 20778194
• Report Number: 1119421-2015-05653
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: VE
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/26/2015

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: Physician Assistant
• Device Expiration Date: 09/30/2017
• Device Model Number: SN6AT8
• Device Catalogue Number: SN6AT8.230
• Device Lot Number: 12189395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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