MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. BIOLON PRIME; SYRINGE

Catalog Number 6301182010

Device Problems Contamination /Decontamination Problem (2895); Insufficient Information (3190)

Patient Problems Foreign Body Sensation in Eye (1869); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/16/2024

Event Type  Injury  

Event Description

During the operation, syringes black threads or particles always flow into the eye directly at the beginning [foreign body in eye] some of the syringes there are black threads or particles [device use issue] case narrative: case (b)(4) is a serious spontaneous case received from other healthcare professional in germany.This report concerns a patient (no patient identifiers reported) of unknown age and gender who experienced the presence of black threads or particles in some of the biolon prime syringes and during operation, syringes black threads or particles always flow into the eye directly at the beginning during treatment with biolon prime (sodium hyaluronate) 12 mg/ml solution for injection, with an unknown dose and route of administration, for an unspecified indication from an unknown start date to an unknown stop date.Lot number: u14998aa and expiration date: oct-2025.It was reported that some biolon prime syringes contained black threads or particles.During the operation, these consistently flowed directly into the eye at the beginning, with the first input.The doctor had to bring the patient back to the operating room (or) several days after the lens implantation because a thread had been left in the eye, obstructing the patient's field of view, and needed to be removed.The doctors had several times mentioned about particles and threads to the reporter but had been unable to show it or capture any of the particles.On (b)(6) 2024, the reporter attended the operating room and observed that they were able to take a photo and save the syringe.The some of the syringes there are black threads or particles and during operation, syringes black threads or particles always flow into the eye directly at the beginning was medically significant.Manufacturer's preliminary comments: a.~for initial and follow-up reports: preliminary results and conclusions of manufacturer's investigation: investigation was started according to initial information received from complaint reporter (nordic pharma distributer) and logged in as complaint qr #(b)(4) in trackwise.Since the investigation is on-going and elementary data is missing, no conclusion can be established yet.The reporter was contacted several times in order to receive the required information to complete the investigation and to achieve preliminary results.B.~initial actions (corrective and/or preventive) implemented by the manufacturer: elementary data is missing to evaluate the case impact, upon receiving of further information and/or preliminary investigation conclusion initial action will be defined.C.~what further investigations do you intend in view of reaching final conclusions? testing of lot retention samples, batch record review, re-occurrence, trending, etc.Cause investigation and conclusion: results of the assessment: according to 'euflexxa and biolon product family hazard master list' (btg-val-030609) this event, taking into consideration worst case scenario, is classified as s3.Action taken to biolon was unknown.No concomitant medication was reported.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = cn (b)(4).Internal # - others = #(b)(4).This ae occurred in germany (eu) and concerns the medical device biolon prime.Please report to your local health authority if required by local law.No corrective action was done by the manufacturer or requested by regulators.

• Brand Name: BIOLON PRIME
• Type of Device: SYRINGE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 18592889
• MDR Text Key: 333896202
• Report Number: 3000164186-2024-00007
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Device Lot Number: U14998AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention