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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS

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AMO PUERTO RICO MFG. INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problem Contamination (1120)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2020
Event Type  malfunction  
Manufacturer Narrative
Patient info: information unknown/ not provided. Lot#: unknown/not provided expiration date: unknown as product lot number was not provided. Udi #: unknown as product lot number was not provided. Phone: (b)(6). Manufacture date: unknown as product lot number was not provided. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that during implantation a particle of plastic was found with the iol in the eye. The particle was removed and kept for investigation. The customer thinks that it is a piece of the cartridge of the iol. No patient injury or other interventions. Through follow-up we learned the customer thinks it is from the lens but are not sure. No additional information was provided.
 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
AMO PUERTO RICO MFG. INC.
road 402 north, anasco ind. pk
anasco PR 00610
Manufacturer Contact
somyata nagpal
road 402 north, anasco ind. pk
anasco, PR 00610
7142478552
MDR Report Key11167255
MDR Text Key234324793
Report Number2648035-2021-07088
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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