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 2016-11-23 for BOSTON CONDITIONING SOLUTION manufactured by Bausch & Lomb Incorporated.
[60845911]
The complaint sample was returned for evaluation and the results of the chemical testing performed were consistent with shelf life limits. Bioburden testing shows a growth identified as paenibacillus sp. Paenibacillus agarivorans (b)(4) was found on the outside of the bottle tip and inside of the cap. There was insufficient sample to perform complete biomedical testing. The testing that were performed were within required specifications. Doctor reported patient's eyelid and skin flares with high pollen season and a history of azelastine eye drops. The doctor cannot determined if the event is related to a specific 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
[60845912]
Consumer reported visiting an allergist for pain in his right eye. Before visiting office, the consumer self-treated with vanicream, desonide cream, pazeo, and ketotifen. Medical information from the allergist indicated patient has a history of perennial allergies and a history of treatment with azelastine (antihistamine) eye drops. The allergist reported the patient's eyelids and skin flare with high pollen season. Office states that patient was seen for inflammation, swelling and redness on the right eye. Doctor diagnosed patient with allergic conjunctivitis. Doctor instructed patient to use tobradex for three days and discontinue contact lens wear. The allergist was unable to determine if the event was related to a specific product. The consumer provided follow-up information that indicated his eye recovered after tobradex use. The consumer reported that when his eye recovered he began wearing his lenses again and also used the lens care product. Patient reported reoccurrence of symptoms and that he has continued to wear his lenses. The consumer has not returned to a health care provider at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[62396974]
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. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001313525-2016-00668 |
| MDR Report Key | 6125232 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-11-23 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2016-12-05 |
| Device Manufacturer Date | 2016-03-06 |
| Date Added to Maude | 2016-11-23 |
| 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 | 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 CONDITIONING SOLUTION |
| Generic Name | PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE |
| Product Code | MRC |
| Date Received | 2016-11-23 |
| Returned To Mfg | 2016-10-07 |
| Lot Number | GC16005 |
| ID Number | NI |
| Device Expiration Date | 2018-03-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-11-23 |