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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 Labelling, Instructions for Use or Training Problem (1318)
Patient Problems Corneal Edema (1791); Hyperemia (1904); Inflammation (1932)
Event Date 01/30/2021
Event Type  malfunction  
Manufacturer Narrative
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. 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/explantable device. Initial reporter telephone number: (b)(6). Device manufacture date: unknown, as 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 patient has developed severe corneal edema and redness in one-day post operation follow up. It was indicated that the cartridge used to implant the intraocular lens did not bear an expiry date. It was noted that when the cartridge was observed closely, it was found to be tampered as the expiry date sticker had been removed. It was noted that the lens was sold/distributed in (b)(6) by a company which has been discontinued/terminated in november 2020. No further 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 Key11389323
MDR Text Key234624629
Report Number2648035-2021-07300
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeIN
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 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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
Event Location No Information
Date Manufacturer Received03/23/2021
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

Patient Treatment Data
Date Received: 02/26/2021 Patient Sequence Number: 1
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