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

Model Number SN6AT5

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Visual Impairment (2138)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.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.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that following and intraocular lens (iol) implant procedure, the patient experienced poor vision.The clinical reason for the exchange is "needs stronger toric iol." the iol was exchanged in a secondary procedure.Additional information was requested.

Event Description

Additional information was provided that in the surgeon's opinion, refractive inconsistency due to keratoconus (no iol problem), caused or contributed to the event.There was no patient harm and the prognosis is good.

Manufacturer Narrative

Additional information provided in a.2., a.3., b.3., b.5., b.6., b.7., d.11., e.4., and h.10.Summary: no supplemental report will be required as the additional information provided indicated that refractive inconsistency due to keratoconus (no iol problem) caused or contributed to the event.Had this information been received prior to submission of the initial medical device report the reported event would not have been reportable.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: 9539779
• MDR Text Key: 173704732
• Report Number: 9612169-2020-00004
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.060
• Device Lot Number: 21148241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES, 8065977763, HWV.; MONARCH III IOL DELIVERY SYST, 8065977773, APD.; ORA W VERIFEYE PLUS SURG CART, 8065998307, ITC.; UNSPECIFIED DUOVISC VISCOELASTIC.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR