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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); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the product was returned to the manufacturing site for evaluation. Visual inspection under magnification revealed that the cartridge was received with a crack that ran from the tube of the cartridge to the tip. The cartridge presented with no further issues. Manufacturing record review: the manufacturing records for the intraocular lens were reviewed. The product was manufactured and released according to specification. The search revealed one additional investigation request (ir) for this production order number has been received, however, complaint was not confirmed based on the investigation. Based on the complaint history review results, no escalation was required. Conclusion: as a result of the investigation there is no indication of a product quality deficiency. 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) had loading issue and the cartridge broke. There was contact with patient's right eye and the lens was removed and replaced in the same procedure. The procedure was completed using another lens of same model and diopter. The event was observed while inserting into the eye. 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
31 technology drive
irvine, CA 92618
7142478552
MDR Report Key14257263
MDR Text Key290447178
Report Number3012236936-2022-00970
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,Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2022
Device Model NumberPSCST30
Device Catalogue NumberPSCST30
Device Lot NumberCJ21692
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
Treatment
Z9002 SN:(B)(4)
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