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

Model Number	SN60WF
Medical Device Problem Codes	Material Opacification (1426); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that after an intraocular lens (iol) procedure, visually significant opacity to the iol material itself was noted.The patient developed ugh(uveitis glaucoma hyphema) syndrome which the haptic poked through the iris.The lens was explanted and patient was left aphakic.Physician sent the explanted lens to an ophthalmic pathologist who was unable to determine anything from the lens.Additional information was requested.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned after being previously sent to a pathologist.The lens was returned submerged in an unknown liquid inside a screw top vial.The lens was removed from the liquid and allowed to dry on a wipe.A large amount of clear matter was dried on and around the edge of the lens, possibly organic in nature.No opacities were observed in the lens material.The lens was sent to the particle lab.The clear material was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the material¿s generated ir spectra to a library of spectra finds the best match to be protein.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported events could not be determined.The lens was returned and no opacities were observed in the lens material.A large amount of clear matter was dried on and around the edge of the lens.The clear material was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the material¿s generated ir spectra to a library of spectra finds the best match to be protein.This was a bilateral file.Information was provided by the surgeon that the patient was treated with prednisolone for 1 month.The ¿deposits¿ on the left lens were 98% better.¿maybe this was in inflammatory in origin and the steroid drops solved it.¿ the manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL 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: 19050033
• Report Number: 1119421-2024-00639
• Device Sequence Number: 8565327
• Product Code: HQL
• UDI-Device Identifier: 00380655093122
• UDI-Public: 00380655093122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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 Expiration Date: 03/17/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.165
• Device Lot Number: 15170263
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female