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 2017-05-24 for PERFLUORON 8065900111 manufactured by Alcon Laboratories, Inc..
[75889127]
No sample or confirmed lot number has been received by manufacturing for evaluation. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75889128]
A doctor reported that a ophthalmic liquid device was used in a patient's right eye during a 23g vitrectomy with pfcl-air-gas exchange procedure. Subsequently, the patient presented with macular atrophy by optic coherence tomography with a severe decrease in central sensitivity and visual acuity. Additional information has been requested. Additional information received confirmed that the patient's current visual acuity is to count fingers with observed macula thickness of 100um.
Patient Sequence No: 1, Text Type: D, B5
[79958026]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79958027]
Additional information was received on a completed questionnaire whereby the ophthalmologist reported that the patient underwent surgery of retinal detachment in the right eye by pars plana vitrectomy 23g scleral buckling, using perfluorocarbon liquid (pfcl) as an intraoperative stabilizer. When pfcl-air was exchanged, paleness of the retina of the posterior pole was noted, especially in the upper half. Ophthalmic c3f8 gas was used as an internal stopper. On (b)(6) 2017, a periocular inflammatory of preseptal cellulitis was detected and treated with antibiotics and intravenous corticosteroids with good evolution. On (b)(6) 2017, with the gas bubble above the middle line, va of 0. 05 was noted. On (b)(6) 2017 after complete reabsorption of the ophthalmic c3f8 gas, a va of 0. 05 was noted. At this moment, macular oct is performed which showed diffuse macular atrophy / thinning. The optic nerve and the layer of nerve fibers of the peripapillary retina are normal. Autofluorescence (af) shows a certain hypo-af when compared to the other eye, as well as moderate hyper-hypo-af in papillomacular bundle. On (b)(6) 2017, fluorescein angiography (fag) was performed, no significant alterations were observed, except mild hyper-f transmitted in papillary-macular bundle. The right eye visual field shows a deep defect of diffuse central sensitivity.
Patient Sequence No: 1, Text Type: D, B5
[114893917]
No sample or confirmed lot code was returned by this customer however, two possible lot codes 257577f and 257579f were provided. No other complaint has been reported for either one of these two possible lot codes. Review of the compounding and filling manufacturing batch records (mbrs) showed no anomalies that may have contributed to the complaint condition. No nonconformances 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 to the 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 condition requirements information. 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 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 process however, this cannot be confirmed. A comprehensive review was performed including a review of the processes, complaint histories, batch record review and finished product testing results. The review shows that the manufacturing processes were in a state of control. Based on the acceptable mbr reviews, finished product test results and the lack of an adverse complaint trend for the two possible lots, these lots continue to be acceptable. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2017-00040 |
| MDR Report Key | 6589164 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-24 |
| Date of Report | 2017-09-12 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NADIA BAILEY |
| 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 | 2017-05-24 |
| Model Number | NA |
| Catalog Number | 8065900111 |
| Lot Number | ASKU |
| 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 | 2017-05-24 |