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Glaucoma Eye Drops Recalled due to Eye Injuries

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The following report has been issued by the MHRA:

Merck Sharp & Dohme Limited

COSOPT Preservative-Free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container

(Dorzolamide / Timolol)

PL 00025/0698
Batch number Expiry date Pack size First distributed
MK13D002 30 April 2015 60 single dose containers 9 September 2013
MK13D004 30 April 2015 60 single dose containers 4 July 2013

Merck Sharp and Dohme is recalling the above batches due to an increase in the number of adverse events and product complaints relating to difficulties with administration received following the introduction of this ‘winged’ presentation in July 2013. A modified design of pipette, which has wings set back from the tip and a more prominent conical tip, has now been introduced as an interim measure to address complaints with the ‘winged’ container. The ‘winged’ presentation is therefore being withdrawn.

Injuries reports include scratches to the cornea, and difficulty in administration of the drops onto the eye.

The wings that extend from the pipette tip and the pieces of plastic that stay on the pipette tip after the pipette is opened make it difficult to use the pipette and increase the risk of eye injury (see picture).

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