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

Model Number	MA60AC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that during implantation of an intraocular lens (iol) extreme problems with the haptic and at the end both haptics were torn off.The lens was explanted.Additional information was requested and received stating that the patient left aphakic, ablatio retinae with oil and carlevale external lens was implanted in other procedure.Informed that the implanted company lens is not qualified to use with company cartridge.
Additional Manufacturer Narrative
The lens was returned submerged in clear liquid inside a small plastic specimen jar.The lens was removed and allowed to air dry prior to evaluation.Both haptics were broken in the haptic insertion areas.The broken haptics were not returned.One haptic insertion area was torn through from optic edge to interior on the anterior and split on the posterior surfaces.The other haptic insertion area was torn on the posterior surface.Both haptic insertion entrances of the optic were cracked on the optic edge.The optic was also cracked on the anterior surface between the optic center and optic edge.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a non-qualified company cartridge and viscoelastic.The company lens model is only qualified for use in the company cartridges.Both haptics were broken.Additional optic damage was also observed.The root cause for the reported complaint was most likely related to a failure to follow the ifu.A non-qualified cartridge and a non-qualified viscoelastic were indicated as associated products.The ifu(instruction for use) 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.Company recommends using the qualified company delivery system or any other company qualified combination.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE 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: 15931051
• Report Number: 1119421-2022-02592
• Device Sequence Number: 4467997
• Product Code: HQL
• UDI-Device Identifier: 00380652552448
• UDI-Public: 00380652552448
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.160
• Device Lot Number: 15325067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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: ALBOMED; MONARCH III IOL CARTRIDGE D; SURGICAL PRODUCT, UNSPECIFIED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male