MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypopyon (1913); Inflammation (1932); Uveitis (2122); Visual Impairment (2138); Vitritis (2181); Fibrosis (3167); Eye Pain (4467)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A physician reported that the panophthalm in right eye.Patient experienced severe pain, significant loss of vision, still uncertain prognosis.Patient underwent vitrectomy for panophthalmia + intravitreal vancomycin 1 mg and ceftazidime 2 mg.Patient was admitted in the hospital for a night.Patient's current status was still fibrin membrane in the anterior chamber in front of the lens that is shrinking, quiet anterior chamber.Additional information has been requested and received stating that this inflammation resulted in a hypopion, fibrin membrane in front of the lens and uveitis.Also vitritis.After vitrectomy and intravitreal vanco 1 mg and ceftazidime 2 mg, treatment was started with topical ophthalmic steroids with anti-infectives and sulfonamide antibiotics forte in high doses per os and fluoroquinolone antibiotics.Physician last saw the patient on 12/02 and there was a calm eye noticed, so a good result (symptoms improving).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that the doctor did not expect that the rootcause would be the company product.
Additional Manufacturer Narrative
The product was not returned for analysis.Information in the fu states that "dr.Did not expect that the root cause would be the company product".The root cause for the reported complaint could not be determined.The sterilisation reports were reviewed and there were no issues with the sterilisation process.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18768208
• Report Number: 9612169-2024-00145
• Device Sequence Number: 11858901
• Product Code: HQL
• UDI-Device Identifier: 00380655093221
• UDI-Public: 00380655093221
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.215
• Device Lot Number: 25648433
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 02/26/2024; 04/15/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/25/2024; 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• 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: AVELOX; BACTRIM; DUOVISC VISCOELASTIC SYSTEM; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; TOBRADEX; UNSPECIFIED MONARCH, PUSHER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male