The device was not returned for evaluation.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.As a lot number was not provided, a dhr (device history record) review could not be performed.Based on all the available information, a root cause could not be determined.
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An online article reported a series of case studies to assess the safety of scleral fixation using the akreos ao60 intraocular lens (iol) and gore-tex suture.The patient underwent a scleral fixation of the iol with gore-tex.Retinal detachment (rd) occurred in one eye (the patient had a rd about 10 years prior), which was observed 20 days after placement of the secondary iol.The recurrent rd was repaired with a pneumatic retinopexy with laser photocoagulation (c3f8+laser).Corneal de-epithelialization was observed after the laser and herpetic keratitis developed a few weeks later.After treatment, the patient developed a central corneal opacity and final bcva was 2.1 logmar.The article reports scleral fixation with an akreos ao60 and gore-tex appears generally safe.
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