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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); Use of Device Problem (1670); Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
Age, weight, and ethnicity: unknown/asked but unavailable. Lot number: unknown, information not provided. Expiration date: unknown, information not provided, as the lot number was not provided. Udi number: a partial udi number is known, as the lot number was not provided. If implanted, give date: not applicable as the cartridge is not an implantable device.   if explanted, give date: not applicable as the cartridge is not an implantable device. Device manufacture date: unknown, information not provided, as the 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 the intraocular lens (iol) did not load correctly and the cartridge had a defect in it. Additional information received revealed that the tip of the cartridge had a fork in it. The cartridge had a split near the tip which was not seen until it was seen in the microscope. Due to this, the lens wrapped around the plunger instead of curling up when the plunger was applied to insert the lens into the patient's operative eye. The tip of the lens was inserted into the eye, however, the lens inserter was pulled out before completely pushing the lens into the eye as the problem was noticed then. No additional intervention was required and the procedure was completed using a different lens and cartridge. 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
road 402 north, anasco ind. pk
anasco, PR 00610
7142478552
MDR Report Key12298536
MDR Text Key265806693
Report Number2648035-2021-08257
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 faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/16/2021
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

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