MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-26 for MONARCH III IOL DELIVERY SYSTEM, INJECTOR 8065977773 manufactured by Alcon Research, Llc - Alcon Precision Device.
[184468529]
A sample product was not returned for analysis. The reporter did not provide any product identifying information, which prevented a product and complaint history search. Additional information was requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184468530]
A doctor reported that during an intraocular lens (iol) implant procedure, the lens was inserted in the eye and removed due to a scratch that was noticed. There was no harm to the patient. Another lens was implanted instead. The scratch was caused by the injector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2020-00048 |
| MDR Report Key | 9759009 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-26 |
| 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 | MONARCH III IOL DELIVERY SYSTEM, INJECTOR |
| Generic Name | LENS, GUIDE, INTRAOCULAR |
| Product Code | KYB |
| Date Received | 2020-02-26 |
| Model Number | III |
| Catalog Number | 8065977773 |
| 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 | 2020-02-26 |