Description of Event or Problem · 1
ON (B)(6) 2010, A SPONTANEOUS REPORT WAS REC'D FROM A PHYSICIAN REGARDING A (B)(6) (ESTIMATED AGE) MALE WHO REC'D AN INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3 % LIDOCAINE). MEDICAL HISTORY INCLUDED A PREVIOUS INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) ON AN UNK DATE WITH NO PROBLEMS; GRAVES' DISEASE; AND UNSPECIFIED TEAR TROUGH DEFORMITY; AND NO ALLERGIES. THE PT'S SKIN TYPE WAS REPORTED AS "OLIVE". CONCOMITANT MEDICATIONS INCLUDED POSSIBLE UNSPECIFIED SUPPLEMENTS. THE PT WAS NOT TAKING ANY OTHER MEDICATIONS. THE PT REC'D A 0.08 CC INJECTION OF RESTYLANE-L ON (B)(6) 2010 FROM A 1 CC SYRINGE TO THE BILATERAL TEAR TROUGHS (0.02 CC TO EACH SITE) AND BILATERAL INFERIOR ORBITAL RIMS (0.02 CC TO EACH SITE) TO CORRECT A "TEAR TROUGH DEFORMITY." PRE-PROCEDURE MEDICATIONS INCLUDED APPLICATION OF TOPICAL LIDOCAINE. NO ADD'L PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2010, APPROX 2 MINS AFTER THE IMPLANTATION, THE PT EXPERIENCED THROBBING PAIN ABOVE AND IN THE RIGHT EYE. THE PT CONCURRENTLY EXPERIENCED A HEADACHE AND AN INFERIOR VISUAL FIELD DISTURBANCE (ALSO REPORTED AS A "VISUAL FIELD DEFICIT" AND "VISUAL FIELD ALTERATION") WHICH WAS FURTHER DESCRIBED AS, THE PT'S VISION SHIFTED INFERIORLY AND TO THE LEFT, WHICH CAUSED THE PT TO "SEE DOUBLE." THE PHYSICIAN REPORTED HE HAD NO WAY OF FORMALLY TESTING THE PT'S VISUAL FIELD; THE PT'S "MUSCLES WERE INTACT" AND THE PT'S VISUAL ACUITY WAS "FINE". IMMEDIATELY AFTER THE PAIN BEGAN, THE PT WAS TREATED WITH AN INJECTION OF VITRASE (HYALURONIDASE) AND UNSPECIFIED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). ACCORDING TO THE PT, ON 2010, ON THE NIGHT OF THE INJECTION, THE PT ALSO DEVELOPED BRUISING IN THE RIGHT LATERAL MALAR AREA, NEAR THE JUNCTION OF THE ZYGOMATIC ARCH AND MAXILLA. THE REPORTING PHYSICIAN ADDITIONALLY REPORTED THAT ON UNSPECIFIED DATES IN (B)(6) 2010, THE PT "SUFFERED" A SUDDEN SUBCONJUNCTIVAL HEMORRHAGE OF THE RIGHT EYE AND HAD ALSO DEVELOPED A 1 CM X 1 CM AREA OF SUPERFICIAL SKIN NECROSIS. THE REPORTING PHYSICIAN FURTHER REPORTED THAT "ALL OF THESE SYMPTOMS HAPPENED AWAY FROM THE INJECTION SITE." ON (B)(6) 2010, THE PT WAS EVALUATED BY AN OPHTHALMOLOGIST, WHO PERFORMED AN ORBITAL ULTRASOUND, WHICH REVEALED NO EVIDENCE OF A HEMATOMA OR RESTYLANE. AS OF (B)(6) 2010, THE PT'S BRUISING HAD WORSENED. THE REPORTING PHYSICIAN CONSIDERED RESTYLANE-L TO BE THE CAUSE OF THE REPORTED EVENTS. THE REPORTING PHYSICIAN ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. THE LOT NUMBER AND EXPIRATION DATE WERE 10518 AND AUG-2011, RESPECTIVELY. ADD'L INFO HAS BEEN REQUESTED.