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

Model Number	SA60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported with a description of intraocular lens (iol) with a description of, the lens material was hanging off on the lens edge after implantation.The material was removed by surgeon during the initial procedure.Additional information received and stated that the patient was not hospitalized for the event and there was no patient harm.
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 number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in b.5., and d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that reporter believed that the reported debris may have originated from the associated company plastic tip wrench.
Additional Manufacturer Narrative
Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The information stated there was "lens material hanging off of lens edge".The lens was not returned to evaluate for damage.The lens remains implanted.Global quality customer affairs (gqca) facilitated a discussion of the investigation process and answered questions from the surgeon regarding this complaint.Information was provided that the surgeon believes that the reported debris may have originated from the associated plastic tip wrench.Surgeon stated that they and the equipment manager decided that in the immediate future the site will use the plastic tip wrench to gently start the phaco hp (hand piece) tip tightening process and complete that process with removing, replacing, and finishing the tightening process using a metal phaco hp tip wrench.File will be reopened in new information is received.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: 14826012
• Report Number: 1119421-2022-01376
• Device Sequence Number: 4677213
• Product Code: HQL
• UDI-Device Identifier: 00380652332552
• UDI-Public: 00380652332552
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2023

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 Model Number: SA60WF
• Device Catalogue Number: SA60WF.145
• Device Lot Number: 15387390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 12/11/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 11/29/2022; 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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: DUOVISC VISCOELASTIC SYSTEM; FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PHACO TIP
• Patient Age: 67 YR
• Patient Sex: Female