MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-05 for TRULIGN TORIC POSTERIOR CHAMBER IOL BL1UT BL1UT2150125 manufactured by Bausch + Lomb.
[183718617]
Though requested, no additional information has been provided by the reporter. The product has not been returned for investigation. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[183718618]
It was reported that an intraocular lens (iol) was explanted due to len vaulting. The formed a u-shape causing progressive hyperopia. Though requested, no additional information is provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00026 |
| MDR Report Key | 9673410 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-02-05 |
| 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 | STEPHANIE ANASTASIOU |
| Manufacturer Street | 21 NORTH PARK PLACE BLVD. |
| Manufacturer City | CLEARWATER FL 33759 |
| Manufacturer Country | US |
| Manufacturer Postal | 33759 |
| Manufacturer Phone | 7277246659 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRULIGN TORIC POSTERIOR CHAMBER IOL |
| Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
| Product Code | MJP |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-02-08 |
| Model Number | BL1UT |
| Catalog Number | BL1UT2150125 |
| Lot Number | 7574405 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 N. GOODMAN ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-02-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |