AMO Recalls "Complete" Brand Multi-purpose Eye Care Solution
KUALA LUMPUR, Nov 22 (Bernama) -- Advanced Medical Optics Inc (AMO), a global ophthalmic surgical and eye care products company, has announced a voluntary recall of specific lots of its Complete brand multi-purpose eye care solution in Malaysia.
These lots were being recalled due to production-line problems at its manufacturing plant in China, which could affect the sterility of the product, the company said in a statement here Wednesday.
AMO vice president, eye care, Asia Pacific, Anthony Chung, said the company has taken proactive and precautionary action even though it believed the likelihood of users in Malaysia experiencing an adverse health event was low based upon its investigation.
"We remain committed to delivering high quality lens care products and will take all necessary measures to remedy this production-line issue," he said.
The company said three lots manufactured for sale in Japan on the same lines were found to be non-sterile and as a result, it conducted a limited product withdrawal in Japan and notified the appropriate global regulatory authorities.
The subsequent investigation traced the manufacturing problem to two of the four production lines in its China facility that manufactured products for the US, Japan and Asia Pacific markets during a specific period of time.
The company has temporarily ceased all manufacturing from the affected production lines and scheduled a special cleaning and sanitization of the plant over the next several weeks.
AMO said that all large bottles (350ml) of the most popular Complete MoisturePLUS are not part of this recall announcement.
The recalled lot numbers are in:
Complete Protec Multi-purpose solution-value pack (2x350ml & 60ml) (ZB02607, ZB03215, ZB03542, ZB03578 and ZB03578),
Complete Moisture Plus 60ml (ZB03094, ZB03195),
Complete Protec Multi-purpose solution 120ml (ZB03123) and
Complete Moisture Plus Starter Kit 60ml (ZB03316 and ZB03710).
Currently, the company is working with the government regulatory authorities on appropriate recall procedures and further detailed information confirming logistics arrangements for this limited and voluntary recall will be forthcoming within one week.
Consumers who believe they are in possession of the recalled product should discontinue use immediately and call Tel: 03-77106311 or e-mail: firstname.lastname@example.org for further instructions.
I still prefer the brand which has the almost similar name with Sensintrovert, from a major pharmacy franchise.
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