CRYSTALENS ACCOMMODATING IOL AT52SE 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 AT52SE UNKNOWN CRYSTALENS IOL manufactured by Bausch + Lomb.

Event Text Entries

[178262906] 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[178262907] Published article - case 2 of 2. A patient who had a monofocal intraocular lens (iol) in the right eye desired cataract surgery in the left eye. The patient previously had a scleral buckle procedure in the left eye. The patient opted for an accommodating iol in the left eye to enhance the near vision in the nondominant eye. Uneventful iol implantation was performed in the left eye. At the one-week visit, the ucdva was 20/40 with a manifest refraction of -0. 25 -1. 00 x75, and the best spectacle-corrected visual acuity (bscva) was 20/20-2. Four weeks later, the patient reported ocular ache and decreased vision. The patient consulted an eye, nose, and throat specialist and sinusitis was ruled out. A retinal specialist also ruled out pain related to the scleral buckle. The manifest refraction was -0. 75 -1. 25 x 80. Slitlamp examination showed no other abnormalities. At nine weeks, the patient presented with continuing eye pain and an increased minus sphere on manifest refraction, -3. 25 -0. 75 x 80, with uncorrected visual acuity (ucva) of 20/60-2. Dilated examination showed the appearance of a z syndrome with stress lines visible on the posterior capsule. An nd:yag laser posterior capsulotomy was performed. Additional laser treatment was applied to areas of the posterior capsule fibrosis that appeared to contribute to the z syndrome. The iol moved back into the proper position during and immediately after the laser treatment. The chronic eye pain also resolved immediately after the nd:yag laser capsulotomy. The manifest refraction was plano -0. 75 x 170; the bscva was 20/25 and the ucdva was 20/40. The intermediate ucva was 20/25, and the near ucva was j2-. 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: 0001313525-2020-00028
• MDR Report Key: 9681580
• 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: AT52SE 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