ENVISTA INTRAOCULAR LENS MX60P MX60P2050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-24 for ENVISTA INTRAOCULAR LENS MX60P MX60P2050 manufactured by Bausch + Lomb.

Event Text Entries

[184828163] The device is not available for evaluation as it remains implanted. The viscoelastic eyefill c used are not validated for use with this lens. The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates. No corrective action required. In the surgeon? S opinion, the likely cause of the event is inflammation due to the combined procedure and reduced compliance of patient to administer eye drops (steroids). Patient was non-compliant with preoperative anti glaucoma therapy and post-operative corticosteroid therapy. The most probable root cause is that this event is patient related.
Patient Sequence No: 1, Text Type: N, H10

[184828164] A user facility in germany reported a patient had a fibrin reaction to the intraocular lens (iol). The patient had a combined phacoemulsification and iol procedure and microshunt (santen) glaucoma procedure. The incision type was clear corneal. The incision was sutured at the time of the surgery (intraoperatively) but removed at the end of the surgery. There was no evidence or suspicion of a wound leak. The procedure was approximately between 15 to 30 minutes long without any complications. No discoloration noted postoperatively. 1-2 days after the surgery, the patient did not experience cloudiness. One week later, an ophthalmologist in the practice noted the cloudiness and referred the patient to the surgeon in the clinic. Three weeks post-surgery, there was suspicion of iol opacification. Slit lamp finding showed grey/opaque iol. Opacification on the front part of iol. It was reported the patient experienced loss of vision, patient? S bcva decreased 1/35. Approximately five weeks post-surgery, a yag-lens polish revealed membrane in the front of the iol surface (possibly inflammatory membrane). There was no opacity of the eye, but fibrin around the lens. With the yag laser, the opacity in front of the lens could be removed centrally, similar to a post-star laser treatment. A second iol polish was performed approximately one week later and a third treatment was performed one week after that. The patient is still undergoing evaluation. A follow up for refraction check was scheduled and the patient is to follow up with the glaucoma department.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001313525-2020-00060
• MDR Report Key: 9870813
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-03-24
• Date of Report: 2020-02-13
• Date of Event: 2020-01-22
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-03-05
• Date Added to Maude: 2020-03-24
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: STEPHANIE ANASTASIOU
• Manufacturer Street: 21 N PARK PL 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

Device Sequence Number: 1

• Brand Name: ENVISTA INTRAOCULAR LENS
• Generic Name: INTRAOCULAR LENS
• Product Code: HQL
• Date Received: 2020-03-24
• Model Number: MX60P
• Catalog Number: MX60P2050
• Lot Number: 3967917
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAUSCH + LOMB
• Manufacturer Address: ROCHESTER NY 14609 US 14609

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-24
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-24