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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

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AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS Back to Search Results
Model Number DCB00
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2022
Event Type  malfunction  
Manufacturer Narrative
Patient weight, and ethnicity and race: not applicable as there was no patient contact.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted; therefore, not explanted.Device evaluation: the product testing could not be performed as the device was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaints were received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported during product handling and prior to insertion the pre-loaded intraocular lens (iol) haptic was bent/broken.There was no patient contact and the lens was not inserted.No further information is available.
 
Manufacturer Narrative
Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 18-jan-2023.Device evaluation: the complaint handpiece and lens were received inside of a bag.Visual inspection under magnification revealed that the complaint lens was received damage, with a portion of the lens separated from the lens in the spare tire around the haptic.The haptic was revealed to have been received stuck inside of the original handpiece and overridden by the plunger rod.The haptic was removed and cleaned as well, revealing that the haptic was damaged.Visual inspection under magnification revealed that the complaint handpiece was received with a portion of the lens stuck inside of the cartridge and overridden by the plunger rod.The handpiece was disassembled, and the assembly was inspected, no issues were observed that could cause or contribute to the observed issues could be identified.Complaint issue "haptic damaged" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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Brand Name
TECNIS SIMPLICITY
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 Key16066164
MDR Text Key308271713
Report Number3012236936-2022-03122
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDCB00
Device Catalogue NumberDCB0000240
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2022
Initial Date FDA Received12/29/2022
Supplement Dates Manufacturer Received01/25/2023
Supplement Dates FDA Received02/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2022
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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