MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-23 for SYNERGEYES HYBRID CONTACT LENS DUH20M-0650 manufactured by Synergeyes.
[4531453]
On (b)(6) 2014, synergeyes received a complaint wherein a contact lens tech (clt) sustained a cut to his hand from opening a vial. Report stated: clt was opening the vial for the 200 vault lens from the ultra health (uh) diagnostic kit to fit the first patient when the top of the bottle, below the neck, cracked off in clt's hand and the raw glass cut his finger. On (b)(6) 2014, synergeyes left a message with (b)(4), an office attendant for eye essentials inc. To have clt call back. On (b)(6) 2014, clt called back and the following information was obtained. On (b)(6) 2014, the cap of the vial was not opening and when clt applied a little more torque with his dominant hand, the vial broke off below the neck; such that the cap, neck, and stopper broke off in one piece. The broken glass cut his right hand. No stitches or any other medical attention was needed, all symptoms of the event have resolved. The vial and accompanying lens have been disposed of as recommended by the synergeyes representative.
Patient Sequence No: 1, Text Type: D, B5
[11910959]
Based on the fact that the lens and vial in question are from an ultra health diagnostic kit, synergeyes determined that the lens cold have been from one of three possible lots: 056400, 057419, 07452 and the vial could have been from two possible vial lots: rc03538 or rc03647. Lots, expiration dates, and manufacture dates: 057419; exp 03/01/2019; mfr date 04/16/2014. Lot 057452; exp 03/01/2019; mfr date 04/18/2014. The dhr was reviewed and no correlation was found between manufacture of product and events. Synergeyes has never had an occurrence of this type of event before.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00016 |
| MDR Report Key | 3934998 |
| Report Source | 05 |
| Date Received | 2014-06-23 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-06-03 |
| Date Mfgr Received | 2014-06-17 |
| Device Manufacturer Date | 2014-02-26 |
| Date Added to Maude | 2014-07-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KINCADE, DIR |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604449636 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGEYES HYBRID CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-06-23 |
| Model Number | DUH20M-0650 |
| Lot Number | 056400 |
| Device Expiration Date | 2019-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGEYES |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-23 |