MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-08 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751512 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[99534830]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[99534831]
A surgeon reported that the patient's posterior capsule was found to be damaged after using the i/a tip with a flaw during a cataract with intraocular lens implant procedure. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[109977086]
One polymer curved i/a tip was returned for evaluation for the report of a burr or flaw that may have resulted in posterior capsule damage. No lot number was identified with this complaint; therefore, a lot history review could not be conducted. A visual inspection was performed and deemed conforming. No flaw, burr, or other visual nonconformance was present with the i/a tip. The complaint evaluation does not confirm the polymer ia tip has nonconforming burr or a flaw. The tip was manufactured to specification. The reason for the posterior capsule damage cannot be determined from this evaluation. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2018-00061 |
| MDR Report Key | 7253168 |
| Date Received | 2018-02-08 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-02-08 |
| 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. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - 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 | DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS |
| Generic Name | DEVICE, IRRIGATION, OCULAR SURGERY |
| Product Code | KYG |
| Date Received | 2018-02-08 |
| Returned To Mfg | 2018-02-09 |
| Model Number | NA |
| Catalog Number | 8065751512 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE |
| Manufacturer Address | 714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-08 |