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

Model Number SN6AT7

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Visual Impairment (2138)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A purchasing agent reported that following an intraocular lens (iol) implant procedure, the patient experienced myopia.The iol was exchanged 3 months following the initial implantation.Additional information was provided indicating that the iol was exchanged for a difference of one diopter.

Manufacturer Narrative

Evaluation summary: the lens was returned.Solution is dried on the lens.The optic is torn/cut into three portions.One portion has additional broken damage observed.A lens bench evaluation could not be conducted due to the lens returned in pieces.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified cartridge and handpiece.The 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.Two viscoelastics were indicated, only one is qualified for the lens/cartridge combination used.The root cause for the complaint of "myopia not tolerated, iol exchanged' cannot be determined.The lens was torn/cut into pieces, typical of an insertion and removal.(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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7613875
• MDR Text Key: 111477784
• Report Number: 1119421-2018-00786
• 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: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7U135
• Device Lot Number: 12313978
• Other Device ID Number: 00380652276320
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR