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

Model Number	SA60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during a cataract extraction with intraocular lens (iol) implant procedure, a very clear mark or scratch was observed in the middle of the lens after the iol was delivered in the bag.The lens has been cut for removal from the patient¿s eye.The replacement lens was used and the surgery was completed.There was patient contact with the product but no patient harm was reported.The patient's symptoms were resolved.Additional information was received stating customer don¿t know why or were the mark/ scratch came from.They more likely think that it was from the forceps, or the handpiece plunger.
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 has been no other complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in the lens case.Viscoelastic was observed on the lens.The lens had been cut into two pieces across the center of the optic.One portion of the optic had an area that had the appearance of lens damage.The area was swabbed.A clear linear material was removed from the optic surface.The material was isolated between glass slides and sent to the lab for identification testing.The clear material was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the opaque residues generated spectra to a library of spectra found the best match to be company cartridge base coat.It cannot be determined if the observed material may have been interpreted as the reported scratch or if the scratch was obscured by the cut across the center of the optic.A qualified iol and handpiece were indicated.The viscoelastic used was not provided.It is unknown if qualified product was used.The product investigation could not identify a root cause for the reported complaint.Based on the iol evaluation and the lab testing results, the reported scratch may have been the observed material.Per the instruction for use (if: the company iol delivery system was for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 14877412
• Report Number: 1119421-2022-01433
• Device Sequence Number: 12030464
• Product Code: HQL
• UDI-Device Identifier: 00380652332712
• UDI-Public: 00380652332712
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 03/01/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.225
• Device Lot Number: 15157438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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 III INJECTOR; MONARCH III CARTRIDGE D; UNSPECIFIED FORCEPS; UNSPECIFIED VISCOELASTIC
• Patient Sex: Unknown