Description of Event or Problem · 1
HYPOPYON[HYPOPYON]. CASE DESCRIPTION: DEVICE REPORT, LOCAL LOG #IOL-00-0731-S-IN, 2000026503IN; A REPORT WAS RECEIVED FROM A PHYSICIAN IN INDIA OF 7 PTS WHO DEVELOPED AN INCREASED INFLAMMATORY REPSONSE AFTER IMPLANT OF CEEON LENS, MODEL 811C (HSM). THIS PT WAS DIAGNOSED WITH A HYPOPYON. THE PT WAS MANAGED CONSERVATIVELY, RESPONDED TO TREATMENT AND RECOVERED. THE PHYSICIAN WAS RELUCTANT TO PROVIDE ANY OTHER DETAILS. NO FURTHER INFO IS EXPECTED. CASE COMMENT: ETIOLOGIES OF HYPOPAY FOLLOWING IOL IMPLANTATION ARE MANY INCLUDING REACTION TO LENS POLISHING COMPOUNDS OR ROUGH EDGES, RESIDUAL LENS PROTEIN, IRIDOCYCLITIS AND OTHER TYPES OF UVEITIS. THIS CASE MAY BE DESCRIBING A STERILE HYPOPYON AS THERE IS NO MENTION OF THE PRESENCE OF INFECTIOUS AGENTS. TRANSIENT HYPOPYON AFTER CATARACT SURGERY IS NOT AN UNCOMMON OCCURRENCE AS SURGICAL MANIPULATIONS MAY LEAD TO INJURY, INFECTION AND/OR IRRITATION. HYPOPYON FOLLOWING IOL IMPLANT IS USUALLY NOT REPORTED TO THE FDA UNLESS (1) THERE IS AN OBJECTIVE CAUSAL CONNECTION THAT THE IOL MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT OR (2) TWO OR MORE EVENTS ARE REPORTED FROM IOLS IN THE SAME LOT. LOT NUMBERS WERE NOT AVAILABLE FOR THIS REPORT. BASED ON THE ABOVE DISCUSSION, RELATEDNESS IS UNLIKELY. IOL INDUSTRY MDR TASK FORCE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MEDICAL PERSONNEL, USER FACILITY, DISTRIBUTOR, MFR OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.