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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
Weight and ethnicity: unknown/ not provided. If implanted, give date: not applicable, as lens was removed/replaced during the same procedure. If explanted, give date: not applicable, as lens was removed/replaced during the same procedure. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that when they were trying to insert the intraocular lens (iol) into the patient's right eye, the unloader (cartridge) split at the tip and ripped the lens and haptics. It was stated that the patient was doing fine. No other information was provided.
 
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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 Key11751154
MDR Text Key265469602
Report Number2648035-2021-07659
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
Report Date 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
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 Received05/06/2021
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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