MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,08 report with the FDA on 2012-07-06 for EAGLE VISION COLLAGEN INSERTS UNK manufactured by Surgical Specialties Corp. (dba Angiotech).
[19043706]
The date of event is estimated. The item/lot code info was not provided. Therefore, the expiration date and manufacturing date are unk. No samples were available for evaluation. Therefore, no testing can be performed. Method: no samples were returned for review. Therefore no evaluation was performed. Results/conclusion: no samples were returned for review. Therefore no evaluation was performed. The item and lot code info was not provided. Therefore, relevant portions of the device history record could not be reviewed. There were no similar events reported for the eagle vision collagen inserts. The root cause for the reported post-operative reaction and events cannot be determined at this time. (b)(4). Item # unk, eagle vision. 4mm collagen inserts, lot unk.
Patient Sequence No: 1, Text Type: N, H10
[19103042]
The distributor forwarded a letter that was received from a pt regarding issues that she believes to be associated with insertion of eagle vision. 4mm collagen inserts back in (b)(6) 2010. The inserts were inserted to remedy dry eye complications in the right eye due to an episode of level five (5) bell's palsy. Approximately one and a half (1 1/2) years later ((b)(6)2011), the pt began to experience eye swelling, discomfort and drainage from the upper right tear duct. She removed a foreign object from her eye which she believed to be a piece of the insert that had not absorbed. Five (5) months later ((b)(6) 2012), the pt was treated for a pyogenic granuloma and abscess in her eye. The doctor also removed three (3) foreign objects from the tear duct at this time. The pt was prescribed a regimen of antibiotics, eye drops and warm compresses to be applied several times a day. The pt was last examined by the physician on (b)(6) 2012. The physician informed her that the state of her eye/tear duct had improved and that he would be weening her off of the medications prescribed for the reported condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522801-2012-00008 |
| MDR Report Key | 2654327 |
| Report Source | 00,08 |
| Date Received | 2012-07-06 |
| Date of Report | 2012-07-05 |
| Date of Event | 2011-12-01 |
| Date Mfgr Received | 2012-06-21 |
| Date Added to Maude | 2012-08-07 |
| 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 | JEFFREY LEWIS, SR. MANAGER |
| Manufacturer Street | 100 DENNIS DR. |
| Manufacturer City | READING PA 19606 |
| Manufacturer Country | US |
| Manufacturer Postal | 19606 |
| Manufacturer Phone | 6104041000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAGLE VISION COLLAGEN INSERTS |
| Generic Name | COLLAGEN INSERTS |
| Product Code | LZU |
| Date Received | 2012-07-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-06 |