CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-2450

MAUDE Adverse Event Report

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 2019-07-10 for CRYSTALENS ACCOMMODATING IOL AO1UV AO1UV-2450 manufactured by Bausch + Lomb.

MAUDE Entry Details

• Report Number: 0001313525-2019-00105
• MDR Report Key: 8778162
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-07-10
• Date of Report: 2019-06-11
• Date of Event: 2019-04-10
• Device Manufacturer Date: 2016-02-03
• Date Added to Maude: 2019-07-10
• 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. TES PROUD
• Manufacturer Street: 1400 NORTH GOODMAN ST.
• Manufacturer City: ROCHESTER NY 14609
• Manufacturer Country: US
• Manufacturer Postal: 14609
• Manufacturer Phone: 5853388549
• Manufacturer G1: BAUSCH AND LOMB
• Manufacturer Street: 21 NORTH PARK PLACE BLVD.
• Manufacturer City: CLEARWATER FL 33759
• Manufacturer Country: US
• Manufacturer Postal Code: 33759
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Generic Name: LENS, INTRAOCULAR, ACCOMMODATIVE
• Product Code: NAA
• Date Received: 2019-07-10
• Model Number: AO1UV
• Catalog Number: AO1UV-2450
• Lot Number: 7641413
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAUSCH + LOMB
• Manufacturer Address: 1400 NORTH GOODMAN ST. ROCHESTER NY 14609 US 14609

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-07-10