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

Model Number	SA60AT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported with a description of lens defective, lens was stuck in the cartridge.The backup lens was used.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.The lens was returned just past the loading area in a company cartridge.Inadequate viscoelastic was observed in the cartridge.The lens was incorrectly pressed up against the roof of the cartridge.The cartridge tip had a large aneurysm on the right side.The cartridge had evidence of placement into a handpiece.The company cartridge was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.The root cause for the reported "lens stuck" appears to be related to a failure to follow the ifu (instructions for use).The lens was incorrectly pressed up against the roof of the cartridge.This would indicate a plunger underride occurred.In addition, inadequate viscoelastic was observed in the cartridge.The cartridge tip had a large aneurysm on the right side.This would indicate the lens/plunger were not in acceptable positions for advancement.Top coat dye stain testing was conducted with acceptable results.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd(ophthalmic viscosurgical device) -filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.It is unknown if a qualified handpiece and viscoelastic were used.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Based on the results from the product history record (iol), the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19132328
• Report Number: 9612169-2024-00338
• Device Sequence Number: 17848916
• Product Code: HQL
• UDI-Device Identifier: 00380650141293
• UDI-Public: 00380650141293
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.330
• Device Lot Number: 25709572
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• Patient Sex: Unknown