An other health care professional reported that during intraocular lens (iol) implantation, a scratch on lens was noticed.Additional information was received.The doctor himself thinks that the scratch might be due to the inside of the cartridge.According to the additional information, the reporter was not sure whether it was a scratch or a temporary dent in the lens, it seemed more like a temporary dent in the lens than a scratch.The lens remains inside the eye.Additional information was received.The scratch was found on the anterior side of the optic.The lens folding went well.According to the reporter perhaps there was a very small burr or crystal on the forceps on the underside of the thin upper leg, (which touches the optic when pushing the iol down) that caused the scratch on lens.However, the scrub nurse could not yet explain this because the forceps were pulled back against the roof of the cartridge, so that this does not scrape the optics.The doctor indicated that the scratch was immediately visible when the iol was still unfolding in the eye, so immediately upon insertion.It seemed on the photos as if the scratch was always present on the trailing haptic, though it could not be entirely said, as the surgeon sometimes rotates the iol during the procedure.The reporter also reported that the iol was sometimes loaded a little early, but had not seen that the dwell time was more that 3 minutes.According to the reporter the dwell time could not be an issue, because the haptics and iol were nicely folded and there was no stretched haptic.The customer had no idea what caused the incident, but speculated it might be the forceps.Everything went smoothly with the lens folding, procedure, and temperature.
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The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The product was not returned.A root cause cannot be determined without physical examination of the product.The instructions for use (ifu) instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.Use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).The training group was made aware of the complaints.Refresher training was conducted for the or personnel regarding loading the intraocular lenses (iols) with respect to proper use of forceps and injector.Both injectors and forceps were replaced.This is being monitored closely.Visits will be conducted to follow up on the retraining.The manufacturer internal reference number is: (b)(4).
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