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 2020-02-14 for ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 4414200001 manufactured by Alcon Research, Llc - Alcon Precision Device.
[183293974]
A sample was not received at the manufacturing site; therefore, the condition of the product could not be verified. A review of the device history record traceable to the possible lot numbers indicates that the product was processed and released according to the product? S acceptance criteria. A sample was not received at the manufacturing site and the device history record review of the lot numbers provided indicated the product was processed and released according to the product? S acceptable criteria, therefore, the root cause for customer complaint issue cannot be determined. The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken. An acceptance quality limit (aql) sampling is performed to ensure that the product meets release acceptance criteria. Non-conforming product is removed from the lot. Complaints are reviewed and monitored at regular intervals for any significant adverse trends. No additional action is required at this time. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183293975]
An ophthalmic surgeon reported that the cannula was well aimed at the lure-lock system, but it "jumped in the operating room". Patient and procedure impact are unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2020-00033 |
| MDR Report Key | 9712898 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-14 |
| 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 RESEARCH, LLC - ALCON PRECISION DEVICE |
| Manufacturer Street | 714 COLUMBIA AVENUE |
| Manufacturer City | SINKING SPRING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC |
| Generic Name | CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2020-02-14 |
| Model Number | NA |
| Catalog Number | 4414200001 |
| 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 RESEARCH, LLC - ALCON PRECISION DEVICE |
| Manufacturer Address | 714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |