MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-12-23 for PERFLUORON 8065900113 manufactured by Alcon Laboratories, Inc..
[63212757]
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).
Patient Sequence No: 1, Text Type: N, H10
[63212758]
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.
Patient Sequence No: 1, Text Type: D, B5
[64741335]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68985385]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2016-00133 |
| MDR Report Key | 6202264 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-12-23 |
| Date of Report | 2017-03-03 |
| Date of Event | 2016-07-15 |
| Date Mfgr Received | 2017-02-22 |
| Date Added to Maude | 2016-12-23 |
| 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. 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 | 8175514846 |
| 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 |
| 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 | 2016-12-23 |
| Model Number | NA |
| Catalog Number | 8065900113 |
| 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. Required No Informationntervention | 2016-12-23 |