MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-10-29 for NON-ABSORBABLE SURGICAL SUTURES 8065710401 manufactured by Alcon Precision Device - Sinking Spring.
[17275380]
A pharmacist assist reported that during corneal suture, a fragment of the polystyrene support, on which the string of the suture kit is placed, entered in the patient's cornea. The particle was impossible to remove during surgery because the fragment was too small. The patient will have a close monitoring to detect any inflammatory reaction related to the presence of this intra corneal foreign body. Additional information has been requested, but not received to date.
Patient Sequence No: 1, Text Type: D, B5
[17522872]
Evaluation summary: one suture lot number was identified with this complaint. No abnormalities that could have contributed to the customer complaint were found during the lot review. Product was released according to manufacturer's acceptance criteria. The suture lot was deemed acceptable with no abnormalities. Suture tensile strengths and diameters were deemed acceptable. The suture sample was not returned and the device history review of the lot number indicated product was released according to manufacturer's acceptance criteria. All suture products are 100% visually inspected, checked for secure component connections and each suture carrier is visually inspected for dirt, a poor die cut, and/or light and dark spots. Any carriers on which defects are found are scrapped during the manufacturing process. The root cause for the complaint issue cannot be determined so no malfunctions were confirmed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2014-00166 |
| MDR Report Key | 4240260 |
| Report Source | 01,05 |
| Date Received | 2014-10-29 |
| Date of Report | 2014-10-08 |
| Date of Event | 2014-10-03 |
| Date Mfgr Received | 2014-10-08 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-11-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| Manufacturer G1 | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Street | 714 COLUMBIA AVE. |
| 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 | NON-ABSORBABLE SURGICAL SUTURES |
| Generic Name | NON-ABSORBABLE SUTURES |
| Product Code | GAS |
| Date Received | 2014-10-29 |
| Model Number | 8065710401 |
| Catalog Number | 8065710401 |
| Lot Number | 959484M |
| ID Number | NA |
| 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 PRECISION DEVICE - SINKING SPRING |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-29 |