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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 Problems Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/30/2021
Event Type  malfunction  
Manufacturer Narrative
Age, weight and ethnicity: unknown/ not provided. Lot number: unknown, information not provided. Expiration date: unknown, as the lot number was not provided. Udi number: a complete udi number is unknown, as the lot number was not provided. Implant date : not applicable as this is not an implantable device. Explant date : not applicable as this is not an implantable device. Initial reporter email address: unknown/not provided. Initial reporter telephone number: (b)(6). Device manufacture date: unknown, as the lot number was not provided. Attempts have been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that there was an irregular transparent plastic shell in the cartridge that went into the patient's operative eye with the intraocular lens (iol). The incision was enlarged to remove the foreign material and sutures was required. No additional information was provided to johnson & johnson surgical vision.
 
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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
1700 e st andrew place
santa ana, CA 92705
7142478552
MDR Report Key12708355
MDR Text Key278774152
Report Number2020664-2021-07919
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
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