DANISH ENDOPHTHALMITIS OUTBREAK

A recent outbreak of endophthalmitis in Denmark highlights the degree to which cataract surgeons are dependent on sterile conditions in the manufacturing of viscoelastics, according to Maria Voss Kyhn MD, PhD, Copenhagen Denmark. The endophthalmitis outbreak occurred in patients who had undergone uncomplicated cataract surgery with a new viscoelastic material, Visco supreme (CLR Medicals), Dr Voss Kyhn told the XXX Congress of the ESCRS. “The only common denominator out of all these patients was the use of Visco supreme during otherwise uncomplicated routine cataract surgery,†she reported.

[caption id='attachment_4833' align='alignright' width='300'] Slit-lamp photo of patient at presentation: hyperemia, hypopyon and fibrinoid
reaction in the anterior chamber[/caption]

The Danish distributor of the product had provided free samples of its new product to several ophthalmic surgeons in Denmark in the autumn of 2011, Dr Voss Kyhn noted. surgeons at these centres used the CE-marked viscoelastic in 93 patients undergoing cataract surgery. Of these, 43 developed severe intraocular reactions within 24 hours. Eight of the cases were referred to Glostrup hospital in Copenhagen within 72 hours, she noted. All presented with severe intraocular fibrinoid reaction and hypopyon and flare in the anterior and posterior chamber. Their visual acuity ranged from hand movements to 0.8. Two patients also presented with retinal haemorrhages.

Two cases with milder symptoms and visual acuities of 0.6 and 0.8 received only local treatment with nepafenac, dexamethasone and ciloxan. Five of the remaining six patients underwent pars plana vitrectomy. One patient had a degree of intraocular reaction and corneal oedema that made vitrectomy impossible, and therefore only underwent vitreous tap. All six received intravitreal injections of vancomycin and ceftazidime.

One patient with a retinal detachment required additional surgery. Another patient, with positive bacterial growth of Bacillus Cereus, required several additional surgical interventions because of recurrent intraocular inflammation with hypopyon after the tapering of local treatment. The patient eventually underwent the removal of both the iOL and the lens capsule. The patient also received weekly injections of ceftazidime for four weeks, in order to control intraocular reaction.

Direct microscopy of vitreous biopsies revealed the presence of many leukocytes, and in two specimens showed a few Gram positive rod-shaped bacteria, Dr Voss Kyhn said. Microbiological culture resulted in the growth of Bacillus Cereus in one of the two specimens examined with positive direct microscopy, she added. Examination of the extracted iOL and lens capsule showed no signs of microorganisms. however, microbiological culturing of samples of the viscoelastic material showed growth of several different Bacillus species in one-third of the samples.

[caption id='attachment_4834' align='alignright' width='300'] Colony forming units of different bacillus species found on culturing of sterile
samples of the viscoelastic[/caption]

Following the outbreak, Dr Voss Kyhn and colleagues reported their findings regarding the contaminated viscoelastic to the Danish health and medicines authority and the health authorities of other EU countries. They in turn immediately suspended the use of Visco supreme. Dr Voss Kyhn noted that surgeons in five other countries have used Visco supreme without any reports of severe intraocular reactions. An investigation of the production facility in the Us did not reveal the source of the contamination.

“Intraocular infection with Bacillus species is a rare cause of postoperative endophthalmitis. however, in posttraumatic endophthalmitis it causes as much as 39 per cent of all cases. The present series of bacillus endophthalmitis was caused by the use of contaminated viscoelastic material in otherwise uncomplicated cataract surgery,†Dr Voss Kyhn concluded.