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

Model Number PCB00

Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Initial reporter telephone number: (b)(6).Device manufacture date: unknown, as serial number was not provided.Device evaluation: product testing could not be performed because the device was not returned for evaluation.None of the packaging was saved for return.The complaint cannot be confirmed.Manufacturing record review: the manufacturing record and complaint history were not reviewed since the serial number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain the missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the theatre staff feels that the internal sterilized wrapping is not sealed firmly enough and could risk the intraocular lens (iol) becoming contaminated.The team's brief description of the event indicated the sterile sealant on the lens packaging is very fragile and it takes a far less effort to open than expected.They have concerns that the contents could easily become desterilized.The customer did not save the packaging for return.No device serial number was provided.No further information was provided.

Manufacturer Narrative

Corrected information: upon further review of the file it was determined that this event is no longer reportable.The customer was dissatisfied about the seal and beliefs that it could risk the lens becoming decontaminated.However, no actual report of an unsterile product was received.Therefore, this supplemental filing is to state that this event is not reportable per additional review of the information received and no further information will be provided.Medical device problem code: 3191 - dissatisfaction with the design was added.Medical device problem code: 1421 - delivered as unsterile product was removed.All pertinent information available to johnson and 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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15773781
• MDR Text Key: 307287695
• Report Number: 3012236936-2022-02734
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCB00
• Device Catalogue Number: UNK-PCB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1