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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR

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AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number 1MTEC30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Uveitis (2122)
Event Type  Injury  
Event Description
It was reported that uveitis developed after implantation of an intraocular lens (iol) and with an imtec30 cartridge. The patient recovered by oral administration of predonine (prednisolone sodium succinate) after a few weeks. The lens remains implanted as of to date. No further information was provided. This emdr report is for the cartridge. A separate report will be submitted for the intraocular lens.
 
Manufacturer Narrative
Age, weight: information unknown/not provided. Date of event: unknown, not provided. If implanted; give date: n/a (not applicable). The cartridge is not an implantable device. If explanted; give date: n/a (not applicable). The cartridge is not an implantable device; therefore, not explanted. (b)(6). The device is not returning for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed. A review of the device lot history record, complaint trending, and risk documentation for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. Attempts have been made to obtain missing information; however, no definitive response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
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Brand NameUNFOLDER PLATINUM 1 SERIES
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
AMO PUERTO RICO MFG. INC.
road 402 north, anasco ind. pk
anasco PR 00610
Manufacturer Contact
somyata nagpal
31 technology drive
irvine, CA 92618
7142478552
MDR Report Key13481516
MDR Text Key289293001
Report Number3012236936-2022-00327
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCJ31516
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/08/2022 Patient Sequence Number: 1
Treatment
ZCW375 LENS, SN UNKNOWN
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