N
Patient 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
MAUDE MDR 6202264
- MDR report key
- 6202264
- Report number
- 1610287-2016-00133
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-07-15
- Date received
- 2016-12-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. RITA LOPEZ
- Address
- 6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
- Phone
- 817-817-8175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PERFLUORON | FLUID, INTRAOCULAR | ALCON LABORATORIES, INC. | LWL | NA | 8065900113 | ASKU | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
AN OPHTHALMIC SURGEON REPORTED THAT SOME HEAVY LIQUID REMAINS INSIDE THE PATIENTS EYE FOLLOWING A VITRECTOMY PROCEDURE FOR REPAIR OF A GIANT RETINAL DETACHMENT. IT WAS NOTED ON THE POSTOPERATIVE VISIT THAT THERE WAS SOME HEAVY LIQUID IN THE ANTERIOR CHAMBER OF THE PATIENT. THE PATIENT WAS TAKEN BACK TO SURGERY TO REMOVE THE HEAVY LIQUID FROM THE ANTERIOR CHAMBER. THE PATIENT IS EXPERIENCING FLOATERS. SINCE THE SURGERY THE PATIENT HAS EXPERIENCED A FOREIGN BODY SENSATION AND ITCHINESS ON HIS BACK WHICH IS WORSE THAN NORMAL. THE PATIENT COMPLAINS THAT THESE SYMPTOMS ARE CAUSED BY THE RESIDUAL HEAVY LIQUID THAT REMAINS INSIDE THE EYE. THE SURGEON NOTED THERE IS NO CASUAL RELATIONSHIP BETWEEN THESE SYMPTOMS AND THE HEAVY LIQUID LEFT INSIDE THE EYE.
N
Patient 1
(B)(4).
N
Patient 1
A CUSTOMER REPORTED A COMPLAINT FROM A (B)(6) YEAR OLD MALE PATIENT WHO HAS RECEIVED A RETINAL DETACHMENT SURGERY ON (B)(6) 2016 THAT THE RESIDUAL HEAVY LIQUID IN HIS LEFT EYE HAS AFFECTED HIS POSTOPERATIVE RESULT. HE HAS FOREIGN BODY SENSATION, AND ITCHINESS ON HIS BACK IS WORSE THAN USUAL. HOWEVER, THE DOCTOR NOTED THAT THERE'S NO CAUSAL RELATIONSHIP AND THIS CASE IS NOT A HEALTH HAZARD. THE PATIENT OBJECTED THE DOCTOR'S OPINION SINCE THE ATTACHED INSTRUCTION MENTIONS THAT PERFLUORON MUST BE COMPLETELY REMOVED FROM A PATIENT EYE UPON COMPLETION OF THE SURGERY. THE RESIDUAL HEAVY LIQUID WHICH ENTERED PATIENT'S ANTERIOR CHAMBER (AC) WAS ALREADY REMOVED ON (B)(6) 2016 AT THE SECOND SURGERY. NO SAMPLE OR LOT CODE WAS RETURNED BY THIS CUSTOMER; THEREFORE, LOT SPECIFIC EVALUATION CANNOT BE COMPLETED, AT THIS TIME. ALL COMPOUNDING, PREPROCESSING, FILLING AND PACKAGING MBRS ARE SUBJECTED TO 2 INDEPENDENT REVIEWS. THE PRODUCT IS MANUFACTURED ACCORDING TO REQUIREMENTS DEVICE MASTER RECORD. THE PRODUCT IS STERILIZED VIA FILTRATION AND FILLED INTO DRY HEAT STERILIZED VIALS THAT ARE SEALED WITH STERILIZED STOPPERS. ALL TESTING FOR THE PRODUCT LOTS ARE REQUIRED TO MEET SPECIFICATIONS PRIOR TO RELEASE. THE PRODUCT INSERT PROVIDES INDICATIONS, INSTRUCTIONS, AND STORAGE CONDITION. CUSTOMER PRODUCT STORAGE AND USE COULD NOT BE CONFIRMED. THE PRODUCT LABELING PROVIDES INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND DIRECTIONS FOR USE TO ENSURE PROPER USE OF THE PRODUCT. INSTRUCTIONS ALSO STATE, ?ALL COMPONENTS FOR SINGLE USE ONLY?. ROOT CAUSE COULD NOT BE DETERMINED. POTENTIAL ROOT CAUSES INCLUDE: PRODUCT NONCONFORMANCE; THIS IS UNLIKELY BASED ON THE COMPOUNDING AND FILLING PROCEDURES AND CONTROLS THAT ARE IN PLACE. NONCONFORMANCE WITH THE KIT SYRINGE, FILTER, OR CANNULA; INCOMING QC INSPECTION ACTIVITIES ARE COMPLETED FOR THE KIT COMPONENTS PRIOR TO RELEASE FOR USE IN PRODUCTION. EVENTS OUTSIDE OF THE MANUFACTURER (E.G. PRODUCT USE, STORAGE CONDITIONS, ETC.); HOWEVER, THIS CANNOT BE CONFIRMED. (B)(4).