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Press Release

Recall of Two Mona Lisa Intrauterine Contraceptive Devices

29 Jul 2011

The Department of Health (DH) today (July 29) instructs a local medical device supplier, CNW Far East Limited (CNWFE), to recall all batches of two of its intrauterine contraceptive devices (IUCDs), Mona Lisa CuT 380A and Mona Lisa NT Cu 380, from the shelf following discovery of mislabelling and wrong packaging involving the two models.

The discovery was found by DH's Chai Wan Maternal and Child Health Centre (MCHC) when they served a family planning client yesterday. On opening a CuT 380A package, staff discovered that an NT Cu 380 device was found instead.

"CuT 380A has a life span of 10 years while NT Cu 380 has only half that - five years," a DH spokesman states. "As the client had expressed no preference on her choice, the NT Cu 380 was inserted and she was also told so," he continues.
Being unusual, MCHC reported the incident to the Medical Device Control Office in DH. The latter began investigation immediately and findings so far reveal that the entire production chain for Mona Lisa IUCDs actually takes place in Belgium.

The spokesman deliberates that though the two devices differ only in terms of life span and DH is not aware of related notifications here or worldwide, to be prudent, the client was contacted. She opted for an alternative mode of contraception on learning the matter.

"Moreover, we have referred the case to our Belgian counterpart for their follow-up. Meanwhile, CNWFE is also instructed to recall both products from the shelf, pending investigation findings in Belgium. However, at present, there is no evidence to indicate that clients with the two devices inserted require removal," the spokesman remarks.

Given that sales record shows that the devices have been distributed to healthcare institutions and private doctors, DH has brought the matter to relevant stakeholders' attention.

"Healthcare professionals and retailers should stop supplying the said products to clients immediately. CNWFE has set up a hotline 2388 2933 to answer related enquiries," the spokesman says.

"And to cater for enquiries from MCHC’s clients, DH will also operate a hotline 2125 1133 from tomorrow onward," the spokesman adds.

The spokesman emphasizes that the DH will be monitoring the recall besides continuing the investigation with Belgian's collaboration.

29 July 2011