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

Model Number DCB00V

Device Problems Difficult to Fold, Unfold or Collapse (1254); Physical Resistance/Sticking (4012)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that after the intraocular lens (iol) was implanted, the trailing haptic remained adhering to the optical part.Since it remained attached and did not unfold, the iol was removed and discarded, and the surgery was successfully completed using the backup iol.There were no patient injuries and no additional medical intervention was required.No further details were provided.

Manufacturer Narrative

Section a2 and a4: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).Section g4: pma/510(k) number: this report is being filed on an international device; tecnis optiblue preloaded 1-piece iol, model dcb00v that has a similar device, tecnis simplicity preloaded 1-piece iol model dcb00 which is distributed in the unites states under pma p980040.Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation, because it was discarded.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: upon further review of the initial mfr report number (b)(4), it was determined that a code describing the unfolding issue with the lens was inadvertently left out of the report.Also, information in section h6 for "type of investigation" and section g2 for 'report source' has been revised.Therefore, the following fields are being corrected to reflect the correct information: report source: 'company representative' was added.Medical device problem code: 1254 was added.Type of investigation: code 4115 applies instead of original code 4114, as the device was discarded.In addition, it was noted that "g4" field for the pma number was inadvertently populated with p980040; the field 'section g4: pma/510(k) number' should have been left blank as the report was being filed on an international device that has a similar device which is distributed in the unites states under pma p980040.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 17996496
• MDR Text Key: 326608185
• Report Number: 3012236936-2023-02506
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636682
• UDI-Public: (01)05050474636682(17)260604
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00V
• Device Catalogue Number: DCB00V0205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian