MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	SN6CWS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Corneal Edema (1791); Hemorrhage/Blood Loss/Bleeding (1888); Retinal Detachment (2047); Vitreous Hemorrhage (2143); Vitreous Detachment (2445); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported during the intraocular lens implantation the surgeon had difficulties implanting the lens, during the surgery a vitreous hemorrhage occurred and the lens could not be placed in the capsule bag but was placed in the sulcus.Three month later he has a visual acuity of approx.0.8.After which there was a retinal detachment that was operated/treated in another hospital.A vitreous rod was passed in the anterior chamber and was removed 8 weeks later with the laser.Additional information was requested and received stating, it was a difficult cataract surgery in a multimorbid patient.The patient had experienced flat anterior chamber, bleeding into anterior chamber.The vitreous hemorrhage occured during the surgery but before the lens was implanted.The patient had experienced bleeding into anterior chamber, vis a tergo, vd, choroidal effusion, expulsive bleeding, posterior capsular rupture and a vitrectomy was done then the lens was inserted into sulcus ciliaris.As per the surgeon the fateful course of the disease, or second surgery, which became necessary after typical nw amotio retinae had caused the event.The lens after implanted into the sulcus was decentered.There was patient impairment and the patient was hospitalized due to retinal detachment, ppv and cerclage as well as endotamponade with gas.
Additional Manufacturer Narrative
The root cause for the reported events could not be determined.Based on the provided information, the reported events may be related to the patient condition and issues during surgery before the lens was implanted.As a result of the issues, which occurred during the surgery, the surgeon chose to implant the company lens into the sulcus ciliaris.The lens subsequently decentered after the pars plana vitrectomy (ppv) was conducted for the retinal detachment, which occurred 3 month after the implant.It is unclear if the incorrect placement of the lens may have contributed to the later events.Per the directions for use company posterior chamber intraocular lenses are intended to be positioned in the posterior chamber of the eye, replacing the natural crystalline lens.This position allows the lens to function as a refractive medium in the correction of aphakia.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 15742037
• Report Number: 1119421-2022-02367
• Device Sequence Number: 5661103
• Product Code: KYB
• UDI-Device Identifier: 00380652249256
• UDI-Public: 00380652249256
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: SN6CWS
• Device Catalogue Number: SN6CWS.220
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 02/08/2023
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female