Optase Dry Eye Intense Drop (Glycerol 0.2%)

Optase Dry Eye Intense Drop (Glycerol 0.2%)

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date
Isoclear Pty Ltd Block C

 

The Village, Block A -1St Floor, c/o Oberon & Glenwood Roads Faerie Glen,0043

 

N/A

 

3V35

3V36

5V45

9V12

 

31 August 2026

30 September 2026

31 March 2027

31 March 2027

 

1’s

 

14 May 2025

14 May 2025

22 August 2025

20 August 2025

 

Class II Type B

 

21 May 2026

 

Brief description of the problem (reason for recall)

This recall is initiated due to recommendation by FDA to Scope because of the citations issued during Manufacturer facility inspection in Jan 2026.

Advice for health professionals and distributors:

We request that you refrain from selling any of the affected batch(s) of Optase Dry Eye Intense Drops 10ml Multi use and return them to your supplying warehouse or distributor with immediate effect. Isoclear Pty Ltd will collect all your stock which will be replaced.

For further product information, please call Isoclear Pty Ltd on contact nr: 012-942-9382.

 

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.

 

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.

Download latest version
Version: 1
Date Updated: 21/05/2026
File Type: www
Category: Product Recall
Unit: Medical Devices, Regulatory Compliance