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

Model Number SN6AT5

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.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.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare worker reported a lens with the "wrong power" was implanted during an intraocular lens (iol) implant procedure.The lens was explanted and replaced approximately two months following the initial procedure.Additional information has been requested.

Manufacturer Narrative

(b)(4).Product evaluation: the product was returned with solution and torn into two pieces, typical of damage created during an explant.Results from the product history record review indicated the product met release criteria.The root cause of the complaint for "explant, wrong power" cannot be determined.The replacement lens was reported to be a 12.5 diopter.Based on the information that the chosen replacement lens was a different lens model and 1.5 diopters less in power, it is possible that the root cause is most likely due to calculation error and not a product malfunction.However, the specific root cause has not been determined and no further information has been provided.

• 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: 5132248
• MDR Text Key: 27805577
• Report Number: 1119421-2015-06371
• 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: other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.140
• Device Lot Number: 12094414
• Other Device ID Number: 00380652250870
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2011
• 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): Required Intervention