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

Model Number	A01UV
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Edema (1820); Eye Injury (1845); Retinal Detachment (2047); Visual Impairment (2138); Vitrectomy (2643)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens (iol) was returned for evaluation in a plastic specimen cup; the original packaging was not returned.The part number and serial number could not be verified, however the lens has the appearance of an ao1uv lens.Visual inspection found the lens cut or torn into three pieces with half the optic missing.One plate was torn off and lying loose in the cup.The other plate was attached to the returned piece of the optic.Both haptic arms were bent.The cause of the damage could not be determined and functional and dimensional testing could not be performed due to the damage.According to bausch and lomb medical reviewer, filamentary keratitis is composed of degenerated epithelial cells and mucus that develops on and adheres to the corneal surface.It generally occurs in association with an underlying condition such as tear deficiency, ocular surgery, and ocular surface abnormalities.Inflammatory cells and fibroblasts just beneath the basal epithelium.Patience is often required in the chronic management of this condition, but is generally good prognosis.Device causality is assessed as "unlikely" and procedure causality as "probable".The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.There have been no other complaints for this lot to date.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the information provided we are unable to determine a root cause.No corrective action is necessary at this time.This investigation is considered complete.If additional information is obtained, the investigation will be reopened and a supplement report will be submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the patient¿s left eye seven months post op due to z syndrome.The patient experienced blurry vision two weeks post original implantation.Six months post op, the surgeon determined the lens orientation had changed and the lens exhibited z syndrome, was cocooned and fibrosed.A lens exchange was conducted seven months post op using a different model iol with the same diopter.Iris retractors were also used.At one-week post lens exchange, the patient experienced 1+ edema, and vision was 20/400.Two weeks post lens exchange, the edema had resolved, and one cornea filament was removed.Vision was 20/30 uncorrected.At one-month post lens exchange, the patient was happy with visual acuity at 20/30+1 uncorrected.At two months post lens exchange the patient presented for an emergency visit and was sent to a retina doctor for macula off retina detachment.A pars plana vitrectomy with gas was performed on the left eye.Current visual acuity for left eye is 20/cf.
Event or Problem Description
It was reported the patient did not have any pre-existing ocular conditions or previous ocular surgeries prior to original implant.The implant procedure was not complicated in any way and was not combined with another surgery.The orientation of the lens did not change after implantation and the optic remained free and clear of imperfections.The patient noticed a decrease in vision prior to implant surgery and refractive error after implant surgery.A second surgical intervention was performed to treat the decrease in vision.In the implanting surgeon's opinion, the later event was caused by z syndrome.
Additional Manufacturer Narrative
There are no changes to the previous assessment based on the new information.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Common Device Name: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 9007264
• Report Number: 0001313525-2019-00143
• Device Sequence Number: 2395673
• Product Code: NAA
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: A01UV
• Device Catalogue Number: A01UV-2100
• Device Lot Number: 7646703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005