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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 EMERALDC30
Device Problems Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Event Description
It was reported that an intraocular lens (iol) was taken out of the patient's operative eye after implantation as the trailing haptic had been detached and remained in the cartridge. A different lens was to be implanted within days. There was no patient injury reported. Account provided that it was likely that the doctor improperly loaded the lens into the cartridge. The account also indicated that the detached haptic issue was caused by the cartridge as the lens did not fit into the cartridge as expected. Account mentioned that loading the lens would be made easier if the cartridge was transparent. No further information was provided.
 
Manufacturer Narrative
Date of event: unknown/no information. 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 device; therefore, not explanted. Phone number: (b)(6). Email address: unknown/no information. (b)(4). The device is not returning for evaluation as it was discarded; 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. 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 Key12849019
MDR Text Key282195640
Report Number3012236936-2021-00069
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/09/2022
Device Model NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device Lot NumberCJ16469
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2021
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: 11/19/2021 Patient Sequence Number: 1
Treatment
INTRAOCULAR LENS, SN UNKNOWN
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