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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 AAB00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Event Date 09/29/2020
Event Type  Injury  
Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that an intraocular lens (iol) was implanted and removed in the same day as the patient's capsule tore.A vitrectomy, incision enlargement and sutures were required.Another johnson & johnson lens (model ar40e 21.0 diopter) was successfully implanted in the sulcus as a replacement.No additional information was provided to johnson & johnson surgical vision.
 
Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 10/21/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the complaint lens was received in the original lens case.The original folding carton, patient stickers, patient id card, customer notes (post-it), and implant notification card were received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, and that the lens was received cut in half (but not separated), which is consistent with a lens handled during removal and replacement.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaints for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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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 Key10731272
MDR Text Key212973512
Report Number2648035-2020-00773
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474548695
UDI-Public(01)05050474548695(17)240318
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
Report Date 12/08/2020
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 Date03/18/2024
Device Model NumberAAB00
Device Catalogue NumberAAB0000215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/23/2020
Supplement Dates Manufacturer Received11/10/2020
Supplement Dates FDA Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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