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

Model Number SN6AT6

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 03/18/2015

Event Type  Injury  

Event Description

Additional information was received by the surgeon that in his opinion the intraocular lens caused/contributed to the event.

Manufacturer Narrative

Evaluation summary:the product was not returned for analysis; it remains implanted.Results from the product history record review indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints for this lot.Investigation has been completed based on current information.(b)(4).

Event Description

A healthcare worker reported following an intraocular lens (iol) implant surgery, the surgeon noted the lens was misaligned.The patient was returned to surgery to rotate the lens as a secondary procedure.The lens remains implanted.Additional information was requested.

Manufacturer Narrative

Summary evaluation: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.There was no valid lot number provided by the reporting facility, therefore it is unknown if there were other complaints in the same lot.Attempts have been made to obtain additional information by phone and fax.A completed questionnaire was not received.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information provided by the surgeon that a secondary procedure to correct the patient's vision was performed.The patient underwent a photorefractive keratectomy.The symptoms are resolved.

• 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 ; mail stop ab2-6; mail stop r3-48; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4769298
• MDR Text Key: 5812780
• Report Number: 1119421-2015-05361
• 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,Health Professional,health professional,oth
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6U165
• Device Lot Number: 12179368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2012
• 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
• Treatment: PREDNISOLONE ACETATE; ILEVRO; CIPROFLOXACIN; LENSX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR