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 2020-03-08 for MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D 8065977763 manufactured by Alcon Research, Llc - Huntington.
[186150195]
The product was returned for analysis. 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. Results from the product history record review indicated the product met release criteria. There have been no other complaints reported in the lot number. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186150196]
A physician reported that during an intraocular lens (iol) implant procedure, an object that appeared to be a transparent foreign material was found around the lens when the lens was implanted into the patient's eye. The iol was not removed due to the foreign material at the back of the lens and the possibility that it might just have been air. The object was still present at day one and two postoperatively, therefore was suspected to be foreign material. It appears that the white transparent object was observed to be adhered at around the 6 o'clock position. It is unknown whether the foreign material was adhered to the lens itself or was adhered to the inner part of the cartridge. There is no plan to remove the foreign material at this time. Additional information was received indicating the patient is experiencing poor vision and anterior inflammation was slightly observed, but within normal range and clinically acceptable. The patient's visual acuity does not improve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00395 |
| MDR Report Key | 9803933 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-08 |
| Date of Report | 2020-03-08 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2020-03-08 |
| 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 - HUNTINGTON |
| Manufacturer Street | 6065 KYLE LANE |
| Manufacturer City | HUNTINGTON WV 25702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 25702 |
| 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, CARTRIDGE D |
| Generic Name | FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) |
| Product Code | MSS |
| Date Received | 2020-03-08 |
| Returned To Mfg | 2020-02-25 |
| Model Number | NA |
| Catalog Number | 8065977763 |
| Lot Number | 32683402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - HUNTINGTON |
| Manufacturer Address | 6065 KYLE LANE HUNTINGTON WV 25702 US 25702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-08 |