MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-12-19 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751511 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[62717436]
A sample has been received and in-house testing is in progress. 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
[62717437]
A surgeon reported that during the polish mode of a cataract extraction with intraocular lens implant procedure the patient experienced a posterior capsule tear. An anterior vitrectomy was performed and the lens was inserted into the sulcus. Upon review of the tip under a microscope the surgeon noted that the tip had a small spur on it. The case was completed without further incident.
Patient Sequence No: 1, Text Type: D, B5
[64044306]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64044307]
New information received from a completed questionnaire indicated that the patients symptoms have resolved.
Patient Sequence No: 1, Text Type: D, B5
[69008145]
One opened ia tip was received in a plastic container for the report of spur at tip. The returned sample was visually inspected. The tip, thread and cannula were conforming. The hub area was non-conforming; the hub was twisted. No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted. A burr as described in the complaint cannot be confirmed from this evaluation, therefore, a root cause for the reported issue cannot be determined for the complaint as described by the customer. A possible root cause for the twisted hub seen in the evaluation is twisting of the cannula/hub assembly with greater force than required the manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2016-00934 |
| MDR Report Key | 6185391 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-19 |
| Date of Report | 2017-03-03 |
| Date of Event | 2016-11-21 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2016-12-19 |
| 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. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| 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 | 3 |
| Brand Name | DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS |
| Generic Name | DEVICE, IRRIGATION, OCULAR SURGERY |
| Product Code | KYG |
| Date Received | 2016-12-19 |
| Returned To Mfg | 2016-12-07 |
| Model Number | NA |
| Catalog Number | 8065751511 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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; 2. Required No Informationntervention | 2016-12-19 |