CRYSTALENS ACCOMMODATING IOL AT50SE UNKNOWN CRYSTALENS IOL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-07 for CRYSTALENS ACCOMMODATING IOL AT50SE UNKNOWN CRYSTALENS IOL manufactured by Bausch + Lomb.

Event Text Entries

[183766620] This case was documented in "two cases of z syndrome with the crystalens after uneventful cataract surgery" by leonard yuen, md, william trattler, md, brian s. Boxer wachler, md. (journal of cataract & refractive surgery 2008; ascrs and escrs). Study author has indicated that there is no further information on this case. The product lot number and serial number are unknown. The product is not available for evaluation. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10

[183766621] Published article - case 1 of 2. The patient had uneventful cataract removal with implantation of a posterior chamber intraocular lens (iol) in the right eye. One day postoperatively no abnormalities were found on slit lamp examination. The patient was instructed to continue with postoperative medications and accommodating exercises with a recommended pair of +2. 00 diopter (d) spectacles. At the two-week visit, the visual acuity had improved. At six weeks, the patient noticed a gradual decrease in uncorrected distance and near visual acuities. Slit lamp examination revealed a vertically tilted iol with a thickened anterior capsule. An anterior capsulotomy was performed at 6 clock hour positions (1, 3, 5, 7, 9, and 11) with a neodymium:yag (nd:yag) laser, and fibrotic band release was successful. The iol straightened immediately, and the patient regained an uncorrected acuity of 20/20 1 day post nd:yag. Six weeks after the nd:yag laser anterior capsulotomy, the uncorrected distance visual acuity (ucdva) in the right eye was 20/20-2, and the uncorrected near visual acuity (ucnva) was 20/60-2, with a manifest refraction of -0. 50 -1. 25 x 167. The anterior capsule had receded, and the iol remained stable. Study author has indicated that there is no further information on this case.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001313525-2020-00027
• MDR Report Key: 9681563
• Report Source: LITERATURE
• Date Received: 2020-02-07
• Date of Report: 2020-01-09
• Date of Event: 2008-11-01
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-07
• Date Added to Maude: 2020-02-07
• 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 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

Device Sequence Number: 1

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Generic Name: LENS, INTRAOCULAR, ACCOMMODATIVE
• Product Code: NAA
• Date Received: 2020-02-07
• Model Number: AT50SE UNKNOWN CRYSTALENS IOL
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAUSCH + LOMB
• Manufacturer Address: 1400 N GOODMAN ROCHESTER NY 14609 US 14609

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-02-07
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-02-07