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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); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
Event Type  malfunction  
Manufacturer Narrative
Weight and ethnicity: unknown, asked but unavailable. Implant date (2021 reports): if implanted, give date: not applicable as this is not an implantable device.   explant date (2021 reports): if explanted, give date: not applicable as this is not an implantable device.   email address: unknown, information not provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that the cartridge cracked while inserting the intraocular lens (iol) and this ripped the lens. It was the cartridge part that is between the body of the cartridge that the lens is loaded into and the opening in the tip that the lens travels through which cracked. The lens was fully inserted into patient's operative eye, but was removed and replaced during the same procedure. Another johnson & johnson lens (same model and diopter) was implanted as a replacement. There was no injury to the patient and no medical/ surgical interventions were required. Patient was doing fine post-op. 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
road 402 north, anasco ind. pk
anasco, PR 00610
7142478552
MDR Report Key12334651
MDR Text Key267053226
Report Number2648035-2021-08315
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 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/06/2022
Device Model NumberPSCST30
Device Catalogue NumberPSCST30
Device Lot NumberCJ18267
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2021
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: 08/17/2021 Patient Sequence Number: 1
Treatment
MODEL Z9002, SERIAL NUMBER (B)(4).
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