MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2016-11-16 for BOSTON SIMPLUS MULTI-ACTION SOLUTION manufactured by Bausch & Lomb Incorporated.
[60029341]
The product was not returned for evaluation. A review of the lot batch record and testing of a retain sample concluded this product was formulated, manufactured and packaged according to local and global specifications. The doctor attributes the event to the product. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[60029342]
Consumer reported she is a first time user of the product and had extreme pain after use. Consumer reported visiting an emergency room and was diagnosed with a corneal abrasion and chemical burn. Medical records received from the emergency department indicated patient visited with complaints of bilateral eye irritation and burning. The record notes patient had a mild corneal abrasion and chemical burn from the eye care product. The emergency department contacted poison control who informed the patient's eyes will be uncomfortable until healed, which should be in 24 hours. The emergency room's final diagnosis was agitation and contact lens corneal abrasion. Patient was prescribed erythromycin ophthalmic ointment and instructed to follow-up with her eye care practitioner. Records received from patient's eye care practitioner indicates patient was diagnosed with chemical conjunctivitis. No corneal abrasion was observed and there is no permanent decrease in visual acuity. Patient was treated with artificial tears and cool compresses. Patient's condition resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2016-00587 |
| MDR Report Key | 6106649 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2016-11-16 |
| Date of Report | 2016-08-23 |
| Date of Event | 2016-08-21 |
| Date Mfgr Received | 2016-08-23 |
| Device Manufacturer Date | 2016-06-10 |
| Date Added to Maude | 2016-11-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SIMPLUS MULTI-ACTION SOLUTION |
| Generic Name | PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE |
| Product Code | MRC |
| Date Received | 2016-11-16 |
| Lot Number | GF16026 |
| ID Number | NI |
| Device Expiration Date | 2019-06-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-16 |