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Lentis HydroSmart intraocular lenses (supplied in glass vials)
Hazard alert and recall - potential for lens to lose transparency
Health professionals and consumers are advised that Device Technologies Australia, in consultation with the TGA, is issuing a hazard alert regarding certain Lentis HydroSmart intraocular lenses (IOLs) and a recall for affected lenses that may remain in the supply chain.
Lentis HydroSmart IOLs are implanted in the eye to replace affected lenses during cataract surgery.
It has been identified that some batches of Lentis HydroSmart IOLs supplied in glass vials from 2006 to 31 December 2011 may be prone to a surface build-up of calcium phosphate in some patients. This build-up is rare, but could lead to the lens becoming less transparent and affect the patient's sight.
Affected IOL models have all been supplied in glass vials and have serial numbers starting with 2000. Identifiers on affected models will all start with the letters:
Lentis HydroSmart IOLs manufactured after 31 December 2011 and those supplied in blister packs are not affected by this issue.
Information for consumers
Device Technologies Australia has contacted ophthalmologists who have implanted affected HydroSmart IOLs to notify them of this issue and provide advice on the appropriate patient follow-up.
You are advised to contact your ophthalmologist immediately if you have had a lens implanted in your eye and are experiencing symptoms of the lens losing transparency. Symptoms of this include:
- gradual decrease of vision
- blurred vision.
If you have unexplained blurred vision do not drive a motor vehicle or operate machinery and talk to a health professional as soon as possible.
If you have any general questions or concerns about IOLs, contact your ophthalmologist.
If you are not experiencing any problems, you should maintain your pre-arranged follow-up program.
Information for all health professionals
Patients with any symptoms that suggest postoperative opacification related to an IOL should be referred to an ophthalmologist, preferably the implanting ophthalmologist.
Information for ophthalmologists
You are advised to be alert to this issue and to follow-up patients who had Lentis HydroSmart IOLs implanted. Check any stocks of Lentis HydroSmart IOLs you may hold for affected models and return them to Device Technologies Australia.
At a reported occurrence rate of 0.011% of all implanted HyroSmart IOLs manufactured since 2006, this issue is rare.
If postoperative opacification is observed, you are advised to evaluate visual acuity levels. If visual acuity is compromised consider surgical IOL replacement.
You are advised to avoid YAG laser capsulotomy in patients with an opacified IOL as this can affect future IOL replacement.
Be aware that in some cases this issue may present bio-microscopic aspects similar to posterior capsule opacification.
If you have any questions or concerns about this issue, contact Device Technologies Australia on 02 9975 5755 or email email@example.com.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.