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

Model Number DCB00

Device Problems Break (1069); Contamination (1120); Inaccurate Delivery (2339)

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

Event Date 08/09/2022

Event Type  malfunction  

Event Description

It was reported that the lead haptic of the preloaded intraocular lens (iol) was opening at an unusual angle that it was twisted while inserting the lens into patient's right eye.The trailing haptic appeared stuck and difficult to remove from the plunger.Additionally, a fiber was identified in the anterior chamber near the leading haptic junction and was removed with forceps.Antibiotic treatment with intracameral cefazolin was administered due to the foreign body identified in the eye after injecting the lens.The lens remains implanted and fiber removed was discarded.Additional information was received from the facility revealing that there were no injuries to the patient and the patient does not have any issue.No other information was provided.

Manufacturer Narrative

Unknown/ asked but not available.If explanted, give date: not applicable, as lens remains implanted in the eye.Telephone number: +011(61)7 3646 7108.The device is not returning for evaluation as the lens remain implanted in the eye.Therefore; a failure analysis of the complaint device cannot be completed.A review of the video, device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Correction: following fields in the report are being corrected after the additional information was received from the facility: section b5: additional information received from the facility had revealed that the intracameral cefazolin was used as routine post op antibiotic.This information was missed to be included in the initial report.With this information, the event is now a case of product malfunction and not a serious injury case.Section b1: report type: the event is just a case of product problem and not adverse event.Section h1: type of reportable event: malfunction, and not serious injury as mentioned in initial report section h6: health effect - impact code: 2199 - no health consequences or impact, and not 4641 - unexpected medical intervention as mentioned in initial report.Additional information: device evaluation: visual inspection of the sample could not be performed since the product was not returned for evaluation.However, a customer provided video was evaluated.The video appears to contain a case of leading haptic not folded or prematurely unfolded but the quality of the video does not allow the appropriate assessment to determine the observation.Conclusion: the complaint issues were not confirmed as the customer provided video did not allow a proper assessment to be made.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & 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: 15340426
• MDR Text Key: 299142241
• Report Number: 3012236936-2022-02324
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636156
• UDI-Public: (01)05050474636156(17)250527
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Female