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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); Crack (1135); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information: weight and ethnicity: unknown, information 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. Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received. Should additional information be received regarding this event the case will be reopened and processed accordingly. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported when inserting the intraocular lens (iol), they tried pushing the iol, and the pscst30 cartridge split at the tip and ripped the lens and haptics. The lens was not stuck in the cartridge and there was no patient injury. Another johnson and johnson lens with the same model and diopter size was implanted in the patient's ocular dexter (right eye). Patient post-op status was reported as doing fine. No further information is available.
 
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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
road 402 north, anasco ind. pk
anasco, PR 00610
7142478552
MDR Report Key11750446
MDR Text Key265017793
Report Number2648035-2021-07637
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 faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2021
Device Model NumberPSCST30
Device Catalogue NumberPSCST30
Device Lot NumberCH14579
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
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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