MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-06-12 for (ALCON) OCUCEL SPEARS 5/PACK, 250/BAG BULK-STERILE 8065913198BS manufactured by Medtronic Xomed, Inc..
[871665]
International affiliate (custom pack) reported to us that they received a complaint from one customer that reported two cases of sands of sahara syndrome (sos) [also known as diffuse lamellar keratitis (dlk)]. Note: this mdr is for case 2 of 2 cases. The surgeon suspects the surgical spears. Pt treated with dexamethasone, neomycin (as preventive treatment). Celestene(betamethason), tobradex every hour since the second surgery. Visual acuity at d+1: 1/10. Presence of diffuse opacities. In 2008 confirmed that a second surgery had already done at d+1. Refractive consequences unk for the moment. Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[8002361]
Alcon submitted mdr's for these same events on 05/09/2008 mfr report # 3002037047-2008-00024 for case 1 of 2 mfr report # 3002037047-2008-00025 for case 2 of 2 three unopened foil packs of ocucel spears have been returned for evaluation. The sponge material meets the current specifications and spear tip has the correct shape. No fiber, flash, loose particulate, and no strings of material were found. No specific defects were identified that could be considered a confirmed cause of the dlk reported by the complainant. The diffuse lamellar keratitis can occur sporadically and has a variety of potential causes including talc from gloves, oil wax, metal fragments, silicates, bacterial endotoxin, epithelial defects, substances produced by laser ablation, particles from eye draped, meibomian gland secretions and povidone iodine. This report shall not be construed as an admission by medtronic xomed that the product(s) herein are or were defective or dangerous in any respect or that any casual relationship exists between these products and any actual or potential injury. In addition, the submission of a report by medtronic xomed shall not be construed as an admission that a reportable event has, in fact, occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2008-00012 |
| MDR Report Key | 1059667 |
| Report Source | 00 |
| Date Received | 2008-06-12 |
| Date of Report | 2008-06-12 |
| Date of Event | 2008-04-03 |
| Date Mfgr Received | 2008-05-15 |
| Device Manufacturer Date | 2007-06-18 |
| Date Added to Maude | 2008-06-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | (ALCON) OCUCEL SPEARS 5/PACK, 250/BAG BULK-STERILE |
| Generic Name | OPHTHALMIC SPONGE - EYE SPEARS |
| Product Code | HOZ |
| Date Received | 2008-06-12 |
| Returned To Mfg | 2008-05-21 |
| Model Number | 8065913198BS |
| Catalog Number | 8065913198BS |
| Lot Number | 51010400 |
| ID Number | 20681490172831 |
| Device Expiration Date | 2010-06-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1028257 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-12 |