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

Model Number SN6AT5

Device Problems Material Integrity Problem (2978); Protective Measures Problem (3015)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/27/2014

Event Type  Injury  

Event Description

A customer reported one week following an intraocular lens (iol) implant surgery a patient noted negative dysphotopsia.Six months later the lens was removed and replaced in a second surgery.Additional information was received that in the surgeon's opinion the "negative dysphotopsia was due to the iol design and the patient's predisposition.".

Manufacturer Narrative

Evaluation summary: product history and batch records were reviewed and documentation indicated the product met release criteria.The file indicated that an associated cartridge was used with a 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 product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional information by email and fax.A completed questionnaire was received.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the initial reporter that the patient had reported a "crescent in a quarter of my view, relentless fluttering.".

• 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: 4855745
• MDR Text Key: 16882319
• Report Number: 1119421-2015-05624
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5U255
• Device Lot Number: 11001390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2015
• Date Device Manufactured: 03/18/2010
• 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: UNSPECIFIED VISCOAT
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR