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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 Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
If implanted, if explanted, give date: not applicable as the lens was inserted, removed and replaced.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that an intraocular lens (iol) was removed from the patient¿s eye because the doctor noticed a defect in or on the lens.It was learned that the complaint was described as debris/spot on lens.The iol was then removed and replaced.No incision enlargement, no vitrectomy, no sutures.No other information was provided.
 
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 (b)(4) and capa (b)(4).
 
Manufacturer Narrative
Additional information: device available for evaluation? yes.Returned to manufacturer on: 7/23/2020.Device returned to manufacturer? yes.Device evaluation: the complaint lens was received in its original lens case.Additionally, the original folding carton, patient stickers, implant notification card, and handwritten notes were received as well.Visual inspection under magnification revealed what appeared to be viscoelastic residue on the optic body and haptics and that the lens was received almost cut in half (not completely separated), which is consistent with a lens that was handled during removal and replacement.The lens was sent for further analysis of what appeared to be viscoelastic residue on the optic body, which may have been the "debris/spot on lens" as described by the customer.Fourier infrared spectroscopy (ftir) analysis indicates that the foreign materials are consistent with sodium hyaluronate, which is consistent with the viscoelastic residue of amo healon.The complaint issue could not be confirmed and therefore no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 Key10317131
MDR Text Key201730812
Report Number2648035-2020-00543
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474548626
UDI-Public(01)05050474548626(17)240316
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 01/01/2005,10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/16/2024
Device Model NumberAAB00
Device Catalogue NumberAAB0000180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 06/25/2020
Initial Date FDA Received07/23/2020
Supplement Dates Manufacturer Received09/03/2020
10/25/2020
Supplement Dates FDA Received09/23/2020
10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
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