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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 ZA9003
Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth, weight, ethnicity: information unknown/not provided.Date of event: the exact date of event is unknown, not provided, but the best estimate date is (b)(6) 2021.Implant date: if implanted, give date: n/a (not applicable).The intraocular lens was not implanted.Explant date: if explanted, give date: n/a (not applicable).The intraocular lens was not implanted.Therefore, lens was not explanted.Initial reporter first & last name: information unknown/not provided.Phone number: (b)(6).All pertinent information available to johnson and johnson surgical vision has been submitted.
 
Event Description
It was reported that the interior pouch of the device was found to be open, that the customer received a lens that was potentially non-sterile.The procedure was completed successfully with a back-up lens.The was no patient contact as the issue was prior to use.There was no patient injury reported.No further information was provided.
 
Manufacturer Narrative
Additional information/corrected data: additional information received as a result of confirming the sample and contents of the complaint at haneda dc (johnson & johnson surgical vision warehouse in tokyo, japan), the outer box was unopened, only the laminate on the outside of the outer box was torn.It is haneda dc center in japan that winds this laminate.Therefore, the initially reported complaint issue of "sterility assurance concern" does not apply to this case.Therefore, based on the new information received the event is no longer reportable and no further information will be provided under this manufacturer report number 2648035-2021-07524.Device evaluation: although the device was not returned to manufacturing site; as per information received from haneda dc, the complaint issue of packaging was confirmed with the sample evaluation, there was no breach of sterility.The outer box was unopened, only the laminate wrap on the outside of the outer box was torn.It is haneda dc that winds this laminate.Based on the product evaluation results, (b)(4) was initiated for haneda dc to further investigate this complaint issue.Manufacturing record evaluation: the manufacturing records for the device were reviewed and no non-conformance report (ncr) was found.The product was manufactured and released according to specifications.A search in complaint system revealed no other complaints have been received for this production order number.Conclusion: based on the product evaluation results, although, the reported "packaging issue" was confirmed; however, the initial report of 'sterility assurance concern' does not apply to this event.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 Key11617924
MDR Text Key243928741
Report Number2648035-2021-07524
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474529021
UDI-Public(01)05050474529021(17)250323
Combination Product (y/n)N
PMA/PMN Number
P990080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 06/04/2021
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 Model NumberZA9003
Device Catalogue NumberZA90030205
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/08/2021
Initial Date FDA Received04/06/2021
Supplement Dates Manufacturer Received05/07/2021
Supplement Dates FDA Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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