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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SENSAR; MONOFOCAL IOLS

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JOHNSON & JOHNSON SURGICAL VISION, INC. SENSAR; MONOFOCAL IOLS Back to Search Results
Model Number AR40M
Device Problem Break (1069)
Patient Problems Hemorrhage/Bleeding (1888); Capsular Bag Tear (2639); Vitrectomy (2643)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It reported after inserting an ar40m intraocular lens (iol) into the patient's operative eye, the haptic broke which resulted in a vitrectomy, and removal of the lens.Through follow up, customer account provided additional information stating a torn capsular bag occurred, vitreous prolapse, and iris bleed with blood falling into the posterior chamber (vitreous hemorrhage).It was also reported the incision was enlarged to allow lens removal, post-op vision reported as poor, suture(s) were required, and the patient left facility (b)(4).No additional information was provided to johnson & johnson surgical vision.
 
Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 07/01/2019.Device evaluation: a visual inspection was performed, the following were the observations: particles/fibers were in lens surface.The two (2) haptics (loops) were detached.There was a haptic detached verified, not a haptic damaged.Based on the visual evaluation of the returned unit, it could not be determined that the cause of the issue reported is related to the manufacturing process since there are indications the unit was handled and explanted.A product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
 
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Brand Name
SENSAR
Type of Device
MONOFOCAL IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
MDR Report Key8724805
MDR Text Key148914563
Report Number2648035-2019-00659
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474514218
UDI-Public(01)05050474514218(17)220605
Combination Product (y/n)Y
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/12/2020
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? Yes
Device Operator Health Professional
Device Expiration Date06/05/2022
Device Model NumberAR40M
Device Catalogue NumberAR40M00015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 05/30/2019
Initial Date FDA Received06/21/2019
Supplement Dates Manufacturer Received07/02/2019
10/25/2020
Supplement Dates FDA Received07/30/2019
11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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