MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-04 for MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D 8065977763 manufactured by Alcon Research, Llc - Huntington.
[181931674]
The used artridge was returned. Inadequate viscoelastic is observed in the cartridge. There is evidence the cartridge was placed into a handpiece. The cartridge nozzle has an aneurysm that changes to a split as it enters the thinner tip material. Heavy stress is also observed. Only half of the lens was found in the returned bag. The haptic was intact on the returned portion. The lens was cut through the center typical of removal. Product history records were reviewed and documentation indicated the product met release criteria. Indicated associated products are qualified for use with the cartridge. The root cause for the reported lens damage may be related to a failure to follow the dfu. There did not appear to be adequate viscoelastic in the cartridge. The dfu instructs to fill the cartridge with viscoelastic before loading the lens. The returned cartridge nozzle has an aneurysm that splits as it extends into the thinner tip area. This type of damage is typically progressive and worsens as the lens is advanced. The damage on the top of the nozzle started in the thick wall cone area. Unusually high internal forces would be needed to create damage in this area. The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced. This type of damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge. If the handpiece plunger is not positioned at the trailing optic edge it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens. There are no other complaints in the reported lot. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181931675]
A facility representative reported that during an intraocular lens (iol) implant procedure, the cartridge cracked and broke the lens haptic as the lens was being pushed through the cartridge tip. The lens was removed and another lens was implanted instead. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00185 |
| MDR Report Key | 9667441 |
| Report Source | OTHER |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2019-11-25 |
| Device Manufacturer Date | 2019-08-13 |
| Date Added to Maude | 2020-02-04 |
| 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. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| 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 | 2020-02-04 |
| Returned To Mfg | 2020-01-14 |
| Model Number | NA |
| Catalog Number | 8065977763 |
| Lot Number | 32726056 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-04 |