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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 Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
Age, weight, ethnicity: information not provided/not available. If implanted, give date: not applicable. The cartridge is not an implantable device. If explanted, give date: not applicable. The cartridge is not an implantable device; therefore, not explanted. (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that there was a little plastic chip inside the cartridge observed during lens implantation into the patient's operative eye. Account's brief description of the event indicated that the cartridge did not break but there was a piece of plastic adhering to the inside of the tip and it touched the patient¿s eye as it was coming out. It was provided that the lens was not affected as it did not suffer any damage and it was not scratched. There was no medical or surgical intervention required. The patient has reportedly fully recovered. No further information has been provided.
 
Manufacturer Narrative
Age, weight, ethnicity: information not provided/not available. If implanted, give date: not applicable. The cartridge is not an implantable device. If explanted, give date: not applicable. The cartridge is not an implantable device; therefore, not explanted. (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that there was a little plastic chip inside the cartridge observed during lens implantation into the patient's operative eye. Account's brief description of the event indicated that the cartridge did not break but there was a piece of plastic adhering to the inside of the tip and it touched the patient¿s eye as it was coming out. It was provided that the lens was not affected as it did not suffer any damage and it was not scratched. There was no medical or surgical intervention required. The patient has reportedly fully recovered. No further information has been provided.
 
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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 Key12993854
MDR Text Key285499480
Report Number3012236936-2021-00226
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeSP
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/25/2022
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCJ22207
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2021
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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