MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-04-25 for PERFLUORON 8065900111 manufactured by Alcon Laboratories, Inc..
[73624542]
No sample or confirmed lot number has been received by manufacturing for evaluation. Four possible lot numbers have been reported. 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. Additional information has been requested. The manufacturer internal reference number is: 2017-32909.
Patient Sequence No: 1, Text Type: N, H10
[73624543]
A surgeon reported retinotoxicity after ophthalmic device liquid was instilled into the right eye of a patient during vitreoretinal surgery on (b)(6) 2017. The patient was treated for rhegmatogenous retinal detachment without macular condition and vitreo hemorrhage. Upon ten day postoperative examination, the affected eye was diagnosed with potential retinotoxicity. Additional information has been requested and received. Relevant test and lab data ((b)(6) 2017): va: light perception and projection in the 4 quadrants, iop: 22 mmhg. Anterior segment: subcapsular posterior paracentral nasal opacity. Eye fund: retina reapplied with adequate pexia at 2 and 7 o'clock. Pale papillae vascular tree attenuation. Image of macular pseudohole. Atrophique alteration of retina with speckled appearance in posterior pole. Fluorescein angiography: delay in arterial filling time. No perifoveal vascular arcade is detected. Lack of arborization of arterial vessels in certain segments. Generalized thinning of retinal vascular tree. Optical tomography of coherence: thinning of all layers of the retina with the disappearance of outer limiting membrane.
Patient Sequence No: 1, Text Type: D, B5
[110118359]
No sample used in the mentioned surgery is available thus, no sample has been received by manufacturing for evaluation. The facility reported four possible lots: 266986f, 257576f, 266985f and 266984f and are not able to distinguish which lot was used in the affected surgery. The reported lots are for the kit which contains the 10cc syringe, 20ga needle, 0. 2 micron filter, a product insert and the 5 ml perfluoro-n-octane liquid unit. A complaint history for the reported possible kit lots and their associated component lot codes was completed and no other complaints were reported. Review of the compounding, filling, blistering and packaging manufacturing batch records (mbrs) showed no anomalies that may have contributed to the complaint condition. No nonconfomances or deviates were noted in the mbrs. All finished product testing results met specifications. The product is manufactured according to requirements of the perfluoro-n-octane device master record. The product is sterilized via filtration through sterilized silastic tubing filled into the dry heat sterilized vials using a peristaltic pump. After setting up the pump fill volume target, the first 42 units are discarded. There are no other solutions or opportunity for other fluid to be introduced into the product vials. The product insert provides indications, instructions and storage conditions. Customer product storage and use could not be confirmed. The product labeling for perfluoro-n-octane liquid 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?. The root cause could not be determined. Potential root causes include: - product nonconformance; however, this is unlikely based on the compounding and filling procedures that were performed as well as the finished product testing results. - nonconformance with the kit syringe, filter or cannula; however, the results of the incoming inspection met specifications for each of these components. - events outside of the manufacturing environment; however, this cannot be confirmed. A comprehensive review was performed including a review of the processes, complaint histories, batch record review, finished product testing results and incoming qc component inspection results. The review shows that the manufacturing processes were in a state of control. Based on the acceptable mbr reviews, incoming qc component inspection results, finished product test results and the lack of an adverse complaint trend for these lots, the reported possible lots continue to be acceptable. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[117970408]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[117970409]
Additional information was received in a letter from the patient's attorney whereby it was stated that the patient has suffered a severe affectation in the conduction of the right pre-chiasmatic visual pathway, that is, an atrophy of the optic nerve without recovery, concluding as a diagnostic hypothesis the retinotoxicity by perfluorocarbon in her right eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2017-00035 |
| MDR Report Key | 6519862 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-25 |
| Date of Report | 2018-04-06 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2017-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON LABORATORIES, INC. |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFLUORON |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2017-04-25 |
| Model Number | NA |
| Catalog Number | 8065900111 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-25 |