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

Model Number AT52SE 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.(b)(4).

Event Description

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.

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: 9681580
• MDR Text Key: 178262906
• Report Number: 0001313525-2020-00028
• 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: AT52SE 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: 75 YR