Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Cooper Vision Hy-Care, All In One Light (AIOL), Refine One Step, Preservative Free Saline

29 Dec 2021

Cooper Vision has issued a medical device safety alert concerning its Hy-Care, All In One Light (AIOL), Refine One Step Peroxide, Preservative Free Saline [Hy-Care, Affected Lot: 170249, 170254, 170577, 170515, 170516, 170522, 170520, 170518, 170519, 170054, 170977, 171199; All in One Light,  Affected Lot: 170444, 170581, 170511, 170513, 170757, 170758, 170844, 170857, 171402; Refine One Step Peroxide, Affected Lot: 170779, 170826; Preservative Free Saline, Affected Lot: 170998].

The manufacturer has discovered that certain bottle types used in their lens care solution and saline products were found to have been manufactured from an incorrect type of high-density polyethylene (HDPE). This might affect the long term stability of the product. Based upon the current testing and information available, the likelihood of any current hazard to the end user is remote and the probability of harm is extremely unlikely. No complaints from users have been received.

The manufacturer advises the following actions to users:

According to the local supplier, the affected products are NOT distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 29 Dec 2021

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