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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 Crack (1135); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/11/2021
Event Type  malfunction  
Manufacturer Narrative
Age, weight and ethnicity: unknown/no information provided. Date of event: exact date unknown/not provided. Best estimate date provided was roughly 2 weeks from (b)(6) 2021. 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 telephone number: (b)(6). It was indicated that the device was discarded therefore a failure analysis of the complaint device cannot be completed. The lot number for this device is not available; therefore, no further investigation can be performed. If there is any further relevant information received, a supplemental medwatch will be filed. Device manufacture date: unknown, as the lot number was not provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that a fragment from 1mtec30 cartridge broke off and was inserted into patient's eye during iol implantation. The fragment was able to be removed from the patient's eye without any injury. Upon follow-up, it was clarified that the cartridge tip cracked and was dislodged into the patient¿s eye but was safely removed. The product was discarded and is not available for return. No further information was available.
 
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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 Key12674345
MDR Text Key277718454
Report Number2020664-2021-07743
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeSN
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
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
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 Received09/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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