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Faulty Eye Product Costs 13 Spaniards Their Sight: Health Officials

by Dr. Trupti Shirole on  November 1, 2015 at 7:47 AM Drug News   - G J E 4
A faulty compound made by German company Alamedics, which is used in eye operations, has cost 13 Spaniards their sight in one eye and has left 28 others also suffering injuries, reported health authorities. Spanish authorities had announced a recall of Ala Octa on June 26, 2015, several days after a distributor raised the alarm over 20 suspect cases in the country.
 Faulty Eye Product Costs 13 Spaniards Their Sight: Health Officials
Faulty Eye Product Costs 13 Spaniards Their Sight: Health Officials
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Government medical agency AEMPS said, "We are aware of 41 cases of people affected by usage of the surgical product Ala Octa, which was recalled by the Spanish health ministry in June 2015 and is suspected of causing loss of vision in several people. There had been 13 confirmed cases of patients being completely blinded in one eye after operations in which Ala Octa was used."

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Other complications included damage to retinal tissue and the optic nerve, inflammations and a loss of sharpness of vision. The 41 cases were reported at 11 health facilities in Spain, primarily in the Basque region near the French border, while Alamedics has pointed to another case in Italy.

Christian Lingenfelder of Alamedics wrote to distributors on July 13, 2015, "The product Ala Octa is suspected of being at the origin of degenerative processes in the retina. Sales have been stopped until the circumstances can be completely clarified."

The Alamedics website describes Ala Octa as chemically and physiologically inert and absolutely non-toxic that can be used in the treatment of several eye conditions, including detached retinas.

AEMPS said, "Samples were sent to a Spanish research institute specialized in ophthalmology for chemical and toxicological analysis. We are working with the pharmaceutical company and German authorities."

France also announced a recall of the product on September 23, 2015.

Mikel Gonzalez, who was blinded in his left eye by his surgery on June 2, said, "I now hope for compensation. A month and a half (after the surgery), they told me that it was a bad product that had made me blind in one eye. At least the health authorities have recognized the case. I hope they will compensate us."

Spanish newspaper El Pais hit out at the German company and at doctors, saying it had taken them too long to raise their concerns over the product.

Source: AFP
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