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

Model Number SN60AT

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported during the implant of an intraocular lens (iol), the lens remained stuck in the cartridge.There is no reported patient impact.Additional information was requested.

Manufacturer Narrative

Additional information provided in d.10., d.11., h.3., h.6., and h.10.The product was returned for analysis and the reported complaint could not be observed.The iol was returned outside the cartridge.Additional observations were as follows: iol returned in a folded position in the iol case.Solution is dried on both surfaces of the optic and haptics.Both haptics are adhered to the optic surface in a folded position.The iol met specifications when dimensionally measured for edge thickness and plan view.The used company ii b cartridge was returned.Viscoelastic was observed in the cartridge.The cartridge has evidence it was placed into a handpiece.No damage observed.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The file states the use of "provisc" as viscoelastic, which is not qualified to be used with the associated products combination.The reported complaint was not observed as the iol was returned outside the cartridge.However, based on the information provided by the customer, the most likely root cause is failure to follow dfu, as the surgeon states the use of non-qualified viscoelastic.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned for analysis.The file states the use of "provisc" as viscoelastic, which is not qualified to be used with the associated products combination.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow the instruction of qualified iol delivery system product combinations and alternative viscoelastic, as the complainant states the use of an unqualified combination.The use of nonqualified combinations may result in delivery issues and/or damage.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 9929658
• MDR Text Key: 187697529
• Report Number: 9612169-2020-00119
• Device Sequence Number: 1
• Product Code: HQL
• 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,Followup
• Report Date: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.350
• Device Lot Number: 21250801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AU00T0V190; MONARCH II B CARTRIDGE; MONARCH II B CARTRIDGE; MONARCH III IOL DELIVERY SYST; MONARCH III IOL DELIVERY SYST; PROVISC