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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 Use of Device Problem (1670); Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
It was reported that the intraocular lens (iol) had loading issue that it advanced too far out of cartridge when trying to insert the lens into patient's left eye. The lens was partially delivered into the eye. The patient has recovered. No further information was provided.
 
Manufacturer Narrative
Lot number: unknown, information not provided. Expiration date: unknown, as the lot number was not provided. Udi number: a partial udi number is known, as the lot number was not provided. Implant date: if implanted, give date: not applicable as this is not an implantable device.   explant date: if explanted, give date: not applicable as this is not an implantable device.   device evaluated by mfr: the device was not returned for analysis. Therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, complaint trending, and risk documentation for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. Device manufacture date: device manufacture date: unknown as lot number was not provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
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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 Key13436393
MDR Text Key294152944
Report Number3012236936-2022-00294
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
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
Date Manufacturer Received01/03/2022
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

Patient Treatment Data
Date Received: 02/03/2022 Patient Sequence Number: 1
Treatment
ZCB00 LENS SN: (B)(4)
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