MAUDE Adverse Event Report: BAUSCH + LOMB CRYSTALENS ACCOMMODATING IOL; LENS, INTRAOCULAR, ACCOMMODATIVE

Model Number AT50SE UNKNOWN CRYSTALENS IOL

Device Problems Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 11/01/2008

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

A review of the trend analysis, risk analysis and directions for use was performed and considered acceptable, with the product performing within anticipated rates.Based on the information available, we are unable to determine a root cause.No corrective action is necessary at this time.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman; rochester NY 14609
• MDR Report Key: 9681563
• MDR Text Key: 183766620
• Report Number: 0001313525-2020-00027
• Device Sequence Number: 1
• Product Code: NAA
• Combination Product (y/n): Y
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AT50SE UNKNOWN CRYSTALENS IOL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR