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

Model Number SN60WF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypopyon (1913); Inflammation (1932); Uveitis (2122); Visual Impairment (2138); Vitritis (2181); Fibrosis (3167); Eye Pain (4467)

Event Date 01/15/2024

Event Type  Injury  

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 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).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received stating that the doctor did not expect that the rootcause would be the company product.

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
• Type of Device: 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
• MDR Text Key: 336118797
• Report Number: 9612169-2024-00145
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AVELOX; BACTRIM; DUOVISC VISCOELASTIC SYSTEM; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; TOBRADEX; UNSPECIFIED MONARCH, PUSHER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male