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

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.

• 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 Key: 11617924
• MDR Text Key: 243928741
• Report Number: 2648035-2021-07524
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529021
• UDI-Public: (01)05050474529021(17)250323
• Combination Product (y/n): N
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• 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 Number: ZA9003
• Device Catalogue Number: ZA90030205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1