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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER SILVER LENS, GUIDE, INTRAOCULAR

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AMO PUERTO RICO MFG. INC. UNFOLDER SILVER LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number PSCST30
Device Problems Break (1069); Mechanical Problem (1384); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Quality issues were reported involving z9002 intraocular lenses (iols) and silver pscst30 cartridges, the lenses are not loading properly, being overwritten, and haptics breaking. No further information is available. This report is for cartridge events. A separate report is being submitted for the lens events.
 
Manufacturer Narrative
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. The device was not returned for analysis. The lot number for this device was 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 product lot number was not provided. Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
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Brand NameUNFOLDER SILVER
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 Key12805620
MDR Text Key282568553
Report Number2020664-2021-08128
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPSCST30
Device Catalogue NumberPSCST30
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 Received10/21/2021
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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