MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-18 for CENTURION SURGICAL PROCEDURE PAK 8065752201 manufactured by Alcon Research, Llc - Houston.
[186120917]
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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186120918]
A customer reported to an account manager the phacoemulsification tip broke in the middle of a procedure. Additional information was received from the surgeon who indicated that during the sculpt phase of a cataract removal with an i-sent and intraocular implant procedure of the right eye, the phacoemulsification tip broke off the handpiece. The surgeon made one pass with tip when he noticed something wrong and pulled it out of the eye. There was no harm to the patient. No additional information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-2020-00153 |
| MDR Report Key | 9848149 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-10-11 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURION SURGICAL PROCEDURE PAK |
| Generic Name | GENERAL SURGERY TRAY (KIT) |
| Product Code | LRO |
| Date Received | 2020-03-18 |
| Model Number | NA |
| Catalog Number | 8065752201 |
| Lot Number | 2325505H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |