MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60AT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during the cataract surgery with intraocular lens implant procedure, something was visually observed before implantation of the lens.After immersing the lens once in the balanced salt solution (bss) and inserting it into the patient's eye found a crack on the edge of the lens.The surgeon suspected a crack and is at the edge of the lens and there was no problem with the patient's refraction or vision.
Additional Manufacturer Narrative
All product and batch history records are quality reviewed prior to product release.The file indicated the use of a qualified cartridge and handpiece.The file also indicates the use of a non-qualified viscoelastic.The root cause for the reported complaint may be related to a failure to follow the ifu.The viscoelastic indicated is not qualified for the lens/company cartridge combination used.The instruction for use (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.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15875783
• Report Number: 1119421-2022-02506
• Device Sequence Number: 14073392
• Product Code: HQL
• UDI-Device Identifier: 00380650130181
• UDI-Public: 00380650130181
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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 Expiration Date: 08/16/2025
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.140
• Device Lot Number: 15087974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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: BSS STERILE IRRIGATING SOLUTION.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; UNSPECIFIED VISCOELASTIC.
• Patient Sex: Unknown