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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 Crack (1135); Inaccurate Delivery (2339); Mechanical Jam (2983); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2021
Event Type  malfunction  
Manufacturer Narrative
Weight, ethnicity: unknown/asked but unavailable. Lot number: unknown, as information was not provided. Expiration date: unknown as product lot number was not provided. Udi number: a complete udi number is unknown as product lot number was not provided. 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. Device manufacture date: unknown, as the lot number was not provided. Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified. Manufacturing record review: the manufacturing record could not be reviewed since the lot number was not provided. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported while inserting the intraocular lens (iol) in the left eye, it got 1/3 of the way when the front haptic and iol got stuck in the cartridge. The surgeon backed the iol off and the lens tore. After the surgeon looked at the cartridge, it was observed cracked. Another johnson & johnson lens (same model and diopter) was implanted as a replacement. There was no vitrectomy, incision enlargement, or sutures required. There was no patient injury. The patient is doing fine post-operatively. Through follow-up, it was learned that the surgeon was attributing the event to the cartridge cracking. The tip of the cartridge was not damaged. No further information was 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
1700 e st andrew place
santa ana, CA 92705
7142478552
MDR Report Key12682419
MDR Text Key278110802
Report Number2020664-2021-07855
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/23/2021
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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