FDA.reportPublic FDA data

MAUDE MDR 9681563

MDR report key
9681563
Report number
0001313525-2020-00027
Event key
0
Event type
3
Date of event
2008-11-01
Date received
2020-02-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEPHANIE ANASTASIOU
Address
21 NORTH PARK PLACE BLVD. CLEARWATER FL 33759 US
Phone
727-727-7277
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CRYSTALENS ACCOMMODATING IOLLENS, INTRAOCULAR, ACCOMMODATIVEBAUSCH + LOMBNAAAT50SE UNKNOWN CRYSTALENS IOLUNKNOWN N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0701. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.