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

Model Number SN6AT7

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

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 lens came out folded from the injector.The surgeon used a new lens.There as no impact to the patient.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.The product was returned for analysis and the reported complaint could not be observed.No cartridge was returned.Additional observations were as follows: iol returned pressed down on one(1) post of the lens case base resulting in gross optic damage.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned.The optic is scratched/marked-rejectable.Unable to conduct dimensional testing due to condition of returned sample.No cartridge returned.The product investigation could not identify the root cause for the reported complaint as only the iol was returned for evaluation.No cartridge was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.The reported complaint is lacking in relevant information such as associated products used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.A functional test (dimensional) to check the dimensions of the lens could not be conducted due to the condition of the returned sample.All product and batch history records are quality reviewed prior to product release.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: 9716626
• MDR Text Key: 183158274
• Report Number: 9612169-2020-00057
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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: SN6AT7
• Device Catalogue Number: SN6AT7.190
• Device Lot Number: 21251785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1