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U.S. Department of Health and Human Services

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

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AMO PUERTO RICO MFG. INC. UNK_SENSAR; INTRAOCULAR LENS Back to Search Results
Model Number UNK-SENSAR
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/15/2023
Event Type  malfunction  
Event Description
It was reported that the intraocular lens (iol) haptics get stuck after implantation into the patient's eye and do not get released easily.It happens in few tecnis 1 and sensar 1 iols.Doctor could not recall and provide the exact serial number for the iols.Manual intervention had to be performed to release the stuck haptics.No patient injury was reported.No further information provided.This report is for the unknown sensar lenses.A separate report is being submitted for the unknown tecnis lenses mentioned in this case.
 
Manufacturer Narrative
Section e1: initial reporter telephone number: (b)(6).Device evaluation: product testing could not be performed as the product was not returned (the lens remains implanted).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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Brand Name
UNK_SENSAR
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 Key17140310
MDR Text Key317854044
Report Number3012236936-2023-01499
Device Sequence Number1
Product Code HQL
UDI-Public(01)
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/15/2023
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 NumberUNK-SENSAR
Device Catalogue NumberUNK-SENSAR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/19/2023
Initial Date FDA Received06/15/2023
Was Device Evaluated by Manufacturer? Yes
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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