MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-18 for ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 8065420020 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[114407288]
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
[114407289]
A customer reported that the cannula came off and plunged through the capsular bag and punctured the retina. Additional information was requested; however, none has been received to date.
Patient Sequence No: 1, Text Type: D, B5
[122525223]
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product? S acceptance criteria. A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue. No sample has been returned for evaluation. No sample was returned and the device history record review of the lot number provided indicated product was released according to product? S acceptance criteria, therefore, the root cause for the defect experienced by the customer cannot be determined. The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken. All cannula assemblies are 100% inspected for luer taper and loose cannula. Any non-conformances found are removed from the lot and scrapped. Complaints are reviewed and monitored at regular intervals for any significant adverse trends. No additional action is required at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2018-00337 |
| MDR Report Key | 7700656 |
| Date Received | 2018-07-18 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2018-02-19 |
| Date Added to Maude | 2018-07-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRYAN BLAKE |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW D-14513 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-14513 |
| 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 | ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC |
| Generic Name | CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2018-07-18 |
| Model Number | NA |
| Catalog Number | 8065420020 |
| Lot Number | 231377M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-07-18 |