MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-31 for RENU SENS. MULTI-PURPOSE SOL.(MILAN) manufactured by Bausch & Lomb Incorporated.
[182796745]
The product was requested, but not returned. A review of the lot batch record concluded that the product was formulated and manufactured according to local and global specifications. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[182796746]
An optician reported that a patient experienced a stinging and burning sensation in both eyes after using a contact lens solution. The patient was seen by an ophthalmologist and was diagnosed with a central corneal ulcer and keratitis in their right eye. The corneal ulcer was 8 mm in diameter and non-infectious. The patient was prescribed tobrex, chibro-cadron, tobradex, cationorm, vitamin a, corticoid, eye lubricants and an eye wash. Over the course of two months the patient began to heal and decreased the use of the lubricant treatment and antibiotics. The ophthalmologist confirmed that the patient has recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00019 |
| MDR Report Key | 9655630 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-01-31 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-02-26 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2020-01-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | BAUSCH + LOMB-IOM S.P.A |
| Manufacturer Street | VIA PASUBIO 34 20050 MACHERIO |
| Manufacturer City | MILAN 20846 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 20846 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENU SENS. MULTI-PURPOSE SOL.(MILAN) |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | LPN |
| Date Received | 2020-01-31 |
| Lot Number | MC0660 |
| Device Expiration Date | 2019-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-01-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-31 |