MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE manufactured by Alcon - Couvreur N.v./alcon - Belgium.
[183876549]
No sample 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183876550]
A health professional reported that viscoelastic product was injected into an eye during a cataract surgery that had just previously received an injection of lidocaine 1% mpf when it was noted that the cornea and subcapsular lens became cloudy and edematous prompting the surgeon to abort the surgery. Follow up activity is scheduled in order to determine when the patient's procedure can be restarted. Additional information has been requested. Additional information received further clarified that upon day one post operative follow up examination, the patient's eye had greatly improved. The patient's procedure will be rescheduled once it is understood what happened in this reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002037047-2020-00007 |
| MDR Report Key | 9842239 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-17 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 028154 |
| 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. Other | 2020-03-17 |