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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_MONOFOCAL IOL; INTRAOCULAR LENS
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AMO PUERTO RICO MFG. INC. UNK_MONOFOCAL IOL; INTRAOCULAR LENS Back to Search Results
Model Number UNKNOWN
Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2022
Event Type  malfunction  
Manufacturer Narrative
Age, weight, and ethnicity: information unknown/not provided.The model number is unknown, as serial number of the device was not provided.Catalog number: the catalog number is unknown, as serial number of the device was not provided.Expiration date: unknown, as serial number of the device was not provided.Unique device identifier (udi #): unknown, as serial number of the device was not provided.Implant date: give date: n/a (not applicable).There is no indication that the device was implanted.Explant date if explanted, give date: n/a (not applicable).There is no indication that the device was implanted.Therefore, not explanted.Initial reporter address: (b)(6).Initial reporter telephone number: (b)(6).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing record review cannot be performed since the serial number is unknown.A complaint historical review of the manufacturing production order number cannot be performed since the serial number is unknown.Conclusion: no sample was returned, and the serial number is unknown, an investigation could not be performed, and no malfunction is confirmed.Device manufacture date: unknown, as serial number of the device was not provided.An attempt was made to obtain the missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that an intraocular lens (iol) was out of the protective case, which caused contamination of the lens.
 
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Brand Name
UNK_MONOFOCAL IOL
Type of Device
INTRAOCULAR LENS
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 Key16373690
MDR Text Key309530035
Report Number3012236936-2023-00355
Device Sequence Number1
Product Code HQL
UDI-Public(01)
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN
Device Catalogue NumberUNK-MONOFOCAL IOL_UNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2023
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
Patient Sequence Number1
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