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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB CRYSTALSERT INSERTER; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

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BAUSCH + LOMB CRYSTALSERT INSERTER; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) Back to Search Results
Model Number CI-28
Device Problem Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Event Date 02/06/2020
Event Type  Injury  
Manufacturer Narrative
The delivery device has not been returned for evaluation.The investigation is on-going.A follow up report will be submitted when additional information becomes available.
 
Event Description
It was reported that upon insertion of the intraocular lens (iol) into the right (od) eye, the haptic tore away from the lens body.The iol damage was noticed intraoperatively and the iol was removed with lens cutters.The capsular bag was damaged and the surgery was aborted due to hemorrhage and a loss of vitreous.A vitrectomy was performed.The incision was not enlarged, but a suture of 10.0 nylon was used.The plan of surgery changed and the patient was left aphakic with no secondary iol implanted until visual status has stabilized.Patient has been referred to a retina specialist with a plan for a 2° anterior chamber (ac) lens later.The patient's prognosis is good.In the physician's opinion, the most likely cause of the iol damage was a defective lens.
 
Manufacturer Narrative
The delivery device was returned for evaluation in the associated intraocular lens (iol) box with the tip bent.The original packaging was not returned.The lot number was not able to be confirmed from the returned device.There was very little dried solution visible in the loading deck or in the tip.Functional testing could not be performed due to the damage.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.The most probable root cause is operational context.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.No corrective action is necessary at this time.
 
Event Description
It was reported that the patient has seen a retina specialist but has not followed up with the implanting surgeon.Though requested, no additional patient outcome information has been received.
 
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Brand Name
CRYSTALSERT INSERTER
Type of Device
FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
Manufacturer (Section D)
BAUSCH + LOMB
1400 north goodman street
rochester NY 14609
MDR Report Key9759334
MDR Text Key183917594
Report Number0001313525-2020-00047
Device Sequence Number1
Product Code MSS
Combination Product (y/n)Y
PMA/PMN Number
K082944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 01/01/2005,02/12/2020
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
Device Operator Health Professional
Device Expiration Date04/09/2020
Device Model NumberCI-28
Device Catalogue NumberCI-28
Device Lot NumberH963802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 02/12/2020
Initial Date FDA Received02/26/2020
Supplement Dates Manufacturer Received03/04/2020
Supplement Dates FDA Received04/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMVISC VISCOELASTIC, CRYSTALENS AO1UV, BAXTER BSS
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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