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

Model Number AT50AO

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

Patient Problem No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the lens is not available for evaluation.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.No similar complaints have been received for this lot number.Subsequent to the reported event, the replacement iol dislocated and had to be repositioned.In the surgeon¿s opinion, the likely cause of lens dislocation of the replacement lens is weak zonules.This secondary event has been deemed unrelated to the second intraocular lens implanted.As the date of diagnosis of weak zonules is unknown it cannot be conclusively determined if the z-syndrome experienced with the reported lens is also related to the weak zonules.The most probable root cause is that this event is related to the patient¿s ocular anatomy.No corrective action is necessary at this time.

Event Description

It was reported that a patient experienced z-syndrome of the intraocular lens (iol) implanted in the left eye.The lens was explanted and replaced with a lens of a different model.Though requested, no additional information has been received.

Event Description

According to the surgeon, the patient¿s weak zonules may have contributed to patient¿s z-syndrome.However, the surgeon did not see the patient prior to cataract surgery and the z-syndrome, so the surgeon is unable to say for sure.The surgeon indicated that the z-syndrome could be related to the patient¿s capsular fibrosis.Per the surgeon, the patient¿s floaters are a result of vitreous synerisis.

Manufacturer Narrative

The conclusions from our original submission remain unchanged.This adverse event is most likely patient-related.

• 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: 9830291
• MDR Text Key: 183918450
• Report Number: 0001313525-2020-00053
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: AT50AO
• Device Catalogue Number: AT50AO2100
• Device Lot Number: 019978
• 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: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR