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

Model Number SN6AT5

Device Problem Overcorrection (3006)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Results from the product history record review indicated the product met release criteria.The root cause for the reported complaint could not be determined.There are no other complaints in the lot.Corrected information: an initial mdr (mfr report # 1119421-2015-06597; submitted 11/15/2015) and a supplemental report (11/18/2015) were submitted for this event under the incorrect manufacturing site of (b)(4).A second supplemental report (mfr report # 9612169-2016-00088; submitted 7/5/2016) was filed correcting the manufacturing site to (b)(4).This current report references the correct manufacturing site (b)(4) in an initial report and provides an explanation linking these report filings.The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmic surgeon reported a cylinder over correction of +2 d following an intraocular lens (iol) implant procedure.Additional information was received from the surgeon that the patient experienced poor vision following the initial intraocular lens (iol) implant procedure and the intraocular lens was removed and replaced in a separate procedure.

• 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 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10063285
• MDR Text Key: 195372673
• Report Number: 9612169-2020-00137
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.105
• Device Lot Number: 21132078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• 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