| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OXYSEPT 1 STEP | SOLUTIONS | JOHNSON & JOHNSON SURGICAL VISION, INC. | LPN | 07167X | ZE04470 | N | |||||
| 101 | --- |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-13 | 0 | 1. R |
Patient 1
AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. LOT NUMBER: UNKNOWN, NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS LOT NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS LOT NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
Patient 1
A REPORT WAS RECEIVED THAT A FEMALE CONSUMER USED OXYSEPT 1STEP PRODUCT, AND REPORTED THAT HER EYE STARTED TO BURN, BLISTER AND BLEED. SHE IMMEDIATELY SOUGHT MEDICAL ATTENTION AND WAS TREATED FOR BURNS. LOCAL ANESTHESIA HAD TO BE USED TO REMOVE THE CONTACT LENS FROM HER EYE. THE CONSUMER RETURNED THE NEXT DAY FOR EXAMINATION. HER EYES WERE IN POOR QUALITY, AND SHE FELT FOREIGN BODY SENSATION. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PRODUCT WAS NOT USED PER THE INSTRUCTIONS FOR USE. THE FOLLOWING MEDICATIONS WERE PRESCRIBED, CHLORAMPHENICOL 1.0% EYE OINTMENT FOR 3 DAYS, PREDNISOLONE SODIUM PHOSPHATE 0.5% ONE DROP 4X A DAY FOR ONE WEEK, CARMELLOSE EYE DROPS 0.5%, TO BE USED ONE DROP EVERY TWO HOURS FOR 10 DAYS, AND (NAME IS NOT READABLE) ONE DROP 4X A DAY FOR ONE WEEK. THE DOCTOR COMMENTED THAT ALTHOUGH THE PRODUCT WAS NOT USED CORRECTLY, THE REACTION SHOULD NOT HAVE BEEN SO SEVERE. NO FURTHER INFORMATION WAS PROVIDED.