MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Codes	Crack (1135); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following a cataract extraction with intraocular lens (iol) implant procedure, the iol was slightly off center observed post three week of initial implantation.The surgeon recommended that patient have surgery to attempt to recenter the lens with a possible exchange.At the beginning of the case it was noted that there was a crack at the optic haptic junction.While attempting to bring the lens into the anterior chamber, that haptic fell off.That haptic was removed from the eye.The surgeon continued attempting to bring the remaining portion of the lens into the anterior chamber when the second haptic just fell off.That haptic was then removed as well and the lens body was removed.A new lens was replaced.
Additional Manufacturer Narrative
The lens was returned inside a plastic specimen cup.Solution was dried on the lens.Both haptics were broken at the gusset area.Both broken haptics were returned in the specimen cup.The optic anterior surface has light scratches.A photo was provided that matches the condition of the returned product.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated a qualified cartridge, handpiece, viscoelastic were used.The explanted lens was returned with both haptics broken.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met alcon¿s release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Qualified associated products were used.The amount of viscoelastic placed into the cartridge prior to lens loading is unknown.The instruction for use (ifu) instructs: the ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices (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.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC 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: 17571316
• Report Number: 1119421-2023-01474
• Device Sequence Number: 8223092
• Product Code: HQL
• UDI-Device Identifier: 00380652251440
• UDI-Public: 00380652251440
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.180
• Device Lot Number: 15526060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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: CLAREON MONARCH IV INJECTOR; DISCOVISC; MONARCH III CARTRIDGE D; UNSPECIFIED FOLDING FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female