MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT2

Device Problems Material Discolored (1170); Appropriate Term/Code Not Available (3191)

Patient Problems Intraocular Pressure Increased (1937); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis, the lens remains implanted.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.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that, following intraocular lens (iol) implant procedure, the patient had experienced glistening effect which affected patient's vision.The patient also experienced blurred vision.Additional information was requested.

Event Description

Additional information was received that, following the iol implant procedure the patient got diabetes and high iop.The lens appeared yellowish.The vision blurring resolved after topical drug treatment; her eye sight went back to baseline.

Manufacturer Narrative

Upon follow up information, the serial number of the suspect product was provided which is not approved for sale in usa.So no further information/reports will be submitted.The manufacturer internal reference number is: (b)(6).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork WV 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork WV 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14019539
• MDR Text Key: 288651085
• Report Number: 1119421-2022-00682
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: SN6AT2
• Device Catalogue Number: SN6AT2.230
• Device Lot Number: 21140147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other