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

Model Number	SN60WF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, upon right evaluation pcl phacodonesis, present subluxed and hanged superior nasal.The iol was explanted and exchanged for a non company lens following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in folded, white gauze material in a small brown envelope.Solution and blood was dried on the lens.The optic was cut into pieces.One optic portion has scratches near the edge.One haptic was bent in the distal area.Associated product information was not provided.It is unknown if qualified associated products were used.Based on information provided by the surgeon, the root cause may be unrelated to the lens.On (b)(6) 2022 upon evaluation of the right eye pcl phacodonesis was present with subluxated lens.On (b)(6) 2023 the lens was removed with a yamane procedure with non-company lens replacement.Surgeon has indicated they are not blaming the lens for the event no further information has been provided at this time.The returned explanted lens was cut into pieces.This was similar in appearance to damage created to help remove a lens from the eye.Additional lens damage was observed.The file indicated that the company 12.0 diopter was replaced with a non-company monofocal 06.0 diopter lens.The 06.0 diopter difference of the replacement lens is suggestive that the event is unrelated to the iol and the replacement lens is an improved selection for this patient's vision needs.It is unknown if qualified products were used with this lens.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.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.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: 17425049
• Report Number: 1119421-2023-01353
• Device Sequence Number: 20316183
• Product Code: HQL
• UDI-Device Identifier: 00380655095652
• UDI-Public: 00380655095652
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: SN60WF
• Device Catalogue Number: SN60WF.120
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 11/12/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Sex: Male