{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "103917256", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A PATIENT SUFFERED AN HEMORRHAGE DURING A VISUALASE SURGERY." }, { "mdr_text_key": "310461164", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL REVIEW OF DATA LOG FILES, PATIENT FOLDER AND POST-OP EXAM WAS PERFORMED, AS PER AS AN IFU AND A TRAINING RECORD REVIEW. IT WAS INVESTIIGATED IF THE HEMORRHAGE MAY BE DUE TO THE INACCURATE PLACEMENT OF THE LASER FIBER, DUE TO AN UNDETECTED INELASTIC MOVEMENT OF THE HEAD FORWARDS. HOWEVER, NOTHING ON IMAGES PERMITED TO DETERMINE A STRICT RELATION BETWEEN THE HEMORRHAGE AND THE LASER FIBER IMPLANT. 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