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

Model Number	CC60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Corneal Edema (1791); Capsular Bag Tear (2639)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.All product and batch history records are quality reviewed prior to product release.Information was provided that a non-qualified cartridge was used.The lens diopter was beyond the range qualified for use in the company cartridge.A qualified handpiece was indicated.Two viscoelastics were indicated, only one was qualified for this lens with the qualified company cartridge combinations.The root cause of the reported complaint was most likely related to a failure to follow the instruction for use (ifu).A non-qualified cartridge and non-qualified viscoelastic was indicated.The lens diopter was larger than the qualified range for the company cartridge.The 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.Company recommends using the qualified company iol delivery system or any other company qualified combination.Information indicated that when the haptics unfolded, that's when the surgeon noticed the broken haptics and proceeded to cut the lens out for a replacement lens of same diopter.However, the capsule bag was stuck to the broken pieces and proceeded to rip the bag apart.The surgeon proceeded to leave the patient aphakic and discharged.The file indicated that the explanted lens was discarded when the surgeon cut the lens out of the patient's eye.There are no other complaints in this 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, upon implantation the haptic detached from the optic.Surgeon had to explant lens.Additional information received and stated that, when the haptics unfolded, that's when the surgeon noticed the broken haptics and proceeded to cut the lens out for a replacement lens of same diopter.However, the capsule bag was stuck to the broken pieces and proceeded to rip the bag apart.The surgeon proceeded to leave the patient aphakic and discharged.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that the patient had substantial persistent corneal edema after the vitrectomy required, after lens removal.Her secondary iol was postponed until cornea cleared.The patient recently underwent secondary scleral fixated iol implantation, however she continues to have persistent corneal edema.Unfortunately, the energy of the required vitrectomy seems to have likely caused some degree of permanent or at least long-standing corneal dysfunction.

• Brand Name: CLAREON ASPHERIC UV ABSORBING 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: 15321924
• Report Number: 1119421-2022-01878
• Device Sequence Number: 14760013
• Product Code: HQL
• UDI-Device Identifier: 00380652396981
• UDI-Public: 00380652396981
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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 Expiration Date: 12/12/2025
• Device Model Number: CC60WF
• Device Lot Number: 15325354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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: CLAREON MONARCH INJECTOR.; HEALON.; MONARCH CARTRIDGE D.; PROVISC.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown