MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 8065440220 manufactured by Alcon Research, Llc - Alcon Precision Device.
[142057994]
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
[142057995]
A physician has noted there were small metal particles noted in this male patient's right eye during surgery. No metallic particles were noted after incision was made with the knife. Some particles have been observed in the incision and at different layers of the stroma, like a small reflex after insertion of viscoelastic with the cannula. Additional information has been requested. This is one of seven reports from this facility. Upon further review of provided information it was noted the surgeon used this cannula to insert dilating drops, other viscoelastic and saline solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612169-2019-00045 |
| MDR Report Key | 8509526 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-04-12 |
| 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. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | ALCON RESEARCH, LLC - ALCON PRECISION DEVICE |
| Manufacturer Street | 714 COLUMBIA AVENUE MODEL FARM ROAD |
| 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 | 0 |
| Brand Name | ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC |
| Generic Name | CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2019-04-12 |
| Model Number | NA |
| Catalog Number | 8065440220 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - ALCON PRECISION DEVICE |
| Manufacturer Address | 714 COLUMBIA AVENUE MODEL FARM ROAD SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |