MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-12 for SYNERGEYES HYBRID DAILY CONTACT LENS CK25S-0050 NA manufactured by Synergeyes, Inc..
[4451813]
On 2014 synergeyes received a complaint wherein the patient experienced a "foreign body" sensation while wearing the contact lens. Synergeyes contacted (b)(6) od, the attending (b)(6) at the university eye associates on (b)(6) 2014 determined the following additional information. On approximately (b)(6) 2014, the patient contacted the (b)(6) and stated that the contact lens was uncomfortable. The patient was instructed by the ecp to discontinue the use of the lens. The patient was not seen by the ecp. On approximately (b)(6) 2014, the patient again reported discomfort while wearing the contact lens. The ecp again instructed the patient to discontinue the use of the lens. The patient was not seen by the ecp. The patient was examined by the ecp on (b)(6) 2014 wherein the patient was found to have a small superficial punctate keratopathy (spk) and minor staining in th e left eye. There was no abrasion or other corneal defect detected during the examination. The lens was inspected by the ecp who determined that there was a "fracture in the lens material. " the ecp advised the patient to discontinue the use of the contact lens and undergo treatment. Patient treatment consisted of discontinuing the use of the lens and wearing an "air-optix day and night" bandage over the left eye for 24 hours. The patient has a pre-existing condition (keratoconus) which may have contributed to the event. Also the patient wore the fractured contact lens after being advised to discontinue the use of the lens. On (b)(6) 2014, the patient was seen by the ecp. The patient was doing "fine" and the spk healed.
Patient Sequence No: 1, Text Type: D, B5
[11796901]
During the investigation the following information was obtained: lens surface was inspected using an optical microscope. There was significant debris/film of optic; indicative of wear for several days/weeks. Minor clouding of skirt indicative of wear for several days/weeks. Significant (3-4 mm) tear in the skirt proximal to gp junction - indicative of wear for several days/weeks and indicative of damage by the patient or ecp damage is consistent with pinching the lens too hard during removal; damaging the lens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005087645-2014-00011 |
| MDR Report Key | 3827845 |
| Report Source | 05 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-03-20 |
| Date Mfgr Received | 2014-04-21 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-05-27 |
| 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 | KAREN KINCADE, DIRECTOR |
| 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 DAILY CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HQD |
| Date Received | 2014-05-12 |
| Returned To Mfg | 2014-04-21 |
| Model Number | CK25S-0050 |
| Catalog Number | NA |
| Lot Number | 055056 |
| Device Expiration Date | 2018-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGEYES, INC. |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-12 |