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U.S. Department of Health and Human Services

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

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AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS Back to Search Results
Model Number PCB00
Device Problems Break (1069); Operating System Becomes Nonfunctional (2996)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown as information was not provided.If implanted, give date: not applicable as the iol was not implanted.If explanted, give date: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported the lens was damaged and shooter would not work.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.Should additional information be received regarding this event the case will be reopened and processed accordingly.No further information is available.
 
Manufacturer Narrative
Device evaluation: product testing could not be performed, because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed, that no additional complaints for this production order number have been received.Conclusion: as a result, of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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Brand Name
TECNIS IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
AMO PUERTO RICO MFG. INC.
road 402 north, anasco ind. pk
anasco PR 00610
MDR Report Key11286191
MDR Text Key233272017
Report Number2648035-2021-07212
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474558359
UDI-Public(01)05050474558359(17)230225
Combination Product (y/n)N
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 03/16/2021
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 Expiration Date02/25/2023
Device Model NumberPCB00
Device Catalogue NumberPCB0000245
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/13/2021
Initial Date FDA Received02/05/2021
Supplement Dates Manufacturer Received02/17/2021
Supplement Dates FDA Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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