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

Model Number SN6AT4

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  malfunction  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the surgeon noticed a foreign body that looked like a piece of plastic in the eye.The foreign body was removed and there was no patient harm.The eye is settling from surgery.Additional information has been requested.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.The reported foreign material was returned for analysis.Additional observations: an empty lens case along with a plastic container was returned for evaluation.No iol was returned for analysis.The reported piece of foreign material was returned inside the referenced plastic container.The material has a plastic aspect and a cylindrical/circular shape.Solution is observed to the plastic appearing material.Upon evaluating the lens case, both pegs from lens locking mechanism of lens cap were found to be broken/torn.The small piece of plastic appears to possibly be one of the pegs from the lens locking mechanism.The lens case posts are intact.No other damage found to the lens case.No cartridge was returned.While we are unable to determine the origin of the reported event, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the root cause for the reported event ¿foreign particles in the eye¿ may be related to a failure to follow the dfu.The complaint states that a hard hemispherical ball with sharp edges was introduced with the iol.It had to be removed from behind the lens.The dfu instructs that prior to insertion, the lens should be carefully examined to ensure that particles have not adhered during handling.Failure to follow this step can cause missing of foreign material/particles stuck on the lens, which could lead to issues/damage during loading and/or undesirable additional medical/surgical intervention after implantation.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: 9716749
• MDR Text Key: 183361247
• Report Number: 9612169-2020-00058
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.185
• Device Lot Number: 21249985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PROVISC