MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for MONARCH III IOL DELIVERY SYSTEM, INJECTOR 8065977773 manufactured by Alcon Research, Llc - Alcon Precision Device.
[146503865]
No injector was returned for evaluation for the report of the injector damaging the lens; therefore, the condition of the product could not be verified. No injector lot number was identified with this complaint; therefore, a lot history review could not be conducted. Because an injector sample was not returned and no lot information was provided, the root cause for the customer complaint issue cannot be determined. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146503866]
A facility representative reported that during an intraocular lens (iol) implant procedure, the handpiece plunger malfunctioned and damaged the lens. The lens was not implanted. There was no patient injury. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2019-00228 |
| MDR Report Key | 8645916 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-28 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-05-28 |
| 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 |
| 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 | MONARCH III IOL DELIVERY SYSTEM, INJECTOR |
| Generic Name | LENS, GUIDE, INTRAOCULAR |
| Product Code | KYB |
| Date Received | 2019-05-28 |
| 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 | 2019-05-28 |