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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR

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AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number 1MTEC30
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
Age, weight and ethnicity: unknown/ not provided. Catalog number : a complete catalog # is unknown, as the serial number was not provided. Lot number: unknown, information not provided. Expiration date: unknown, as the serial number was not provided. Udi number: a complete udi number is unknown, as the serial number was not provided. Implant date : not applicable as this is not an implantable device. Explant date : not applicable as this is not an implantable device. Initial reporter telephone number: (b)(6). Device manufacture date: unknown, as the serial number was not provided. Device evaluation: the product testing could not be performed as the product was not returned. The reported complaint cannot be confirmed. Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown. Since the serial number is unknown, the complaint history review could not be performed. Conclusion: since the sample of the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency. An attempt has 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) could not advance through the cartridge. Doctor reloaded with a new lens using the same cartridge and when they advance the lens, a piece of plastic came out with into the eye. Attempt made for information on the iol but not available. No further information available.
 
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Brand NameUNFOLDER PLATINUM 1 SERIES
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 Key12105553
MDR Text Key265606829
Report Number2648035-2021-08080
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberUNKNOWN
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 Received06/03/2021
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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