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

Model Number SN6AT3

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 04/21/2020

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.(b)(4).

Event Description

A health professional reported that after an intraocular lens (iol) implant surgery, a patient is experiencing uncorrected astigmatism.In the right eye.Additional information was requested and received with the preoperative and postoperative measurements including the target refraction.

Event Description

Additional information received stating the iol was not explanted and at the last visit to the eye clinic on (b)(6) 2020, the condition was unchanged and without any complications.

Manufacturer Narrative

Additional information provided in b.5., and b.6.Corrected information provided in b.6.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 10641377
• MDR Text Key: 210255648
• Report Number: 9612169-2020-00208
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.195
• Device Lot Number: 21254626
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGE; MONARCH III IOL HANDPIECE; MONARCH III D CARTRIDGE; MONARCH III IOL HANDPIECE
• Patient Outcome(s): Other