MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE manufactured by Alcon - Couvreur N.v./alcon - Belgium.
[184696458]
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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184696459]
A surgeon reported a patient experienced a corneal burn during a cataract extraction procedure. The patient had a small anterior chamber, therefore it was necessary to use a greater amount of ophthalmic viscoelastic (ovd) to inflate the anterior chamber. The phacoemulsification (phaco) tip filled with the ovd upon insertion of the tip into the eye. The ovd was crystallized upon activation of the handpiece and the phaco tip clogged. Without cooling the burn was immediate. The occlusion alarm from the system did sound and was heard by the surgeon, but he did not realize the severity until the burn was noted. The tip was removed form the eye, rinsed and unclogged and the case was completed. A suture was required to close the wound. On post operative day one the patient presented with endothelial detachment and corneal folds. Additional information has been requested and received. Additional information received indicated that this ovd is not the usual ovd used by this surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002037047-2020-00010 |
| MDR Report Key | 9872072 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-24 |
| 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 | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON - COUVREUR N.V./ALCON - BELGIUM |
| Manufacturer Street | RIJKSWEG 14 |
| Manufacturer City | PUURS B-2870 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | B-2870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE |
| Generic Name | AID, SURGICAL, VISCOELASTIC |
| Product Code | LZP |
| Date Received | 2020-03-24 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON - COUVREUR N.V./ALCON - BELGIUM |
| Manufacturer Address | RIJKSWEG 14 PUURS B-2870 BE B-2870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |