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

Model Number DCB00

Device Problems Contamination (1120); Scratched Material (3020); Physical Resistance/Sticking (4012)

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

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

Section a4 (patient weight), a5 (ethnicity): unknown/ asked but not available.Section d6b: if explanted, give date: not applicable as the lens remains implanted.Section h3-other (81): the intraocular lens (iol) was not returned for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A doctor reported that he had an intraocular lens (iol) where the trailing haptic was stuck to the lens which he said to be not uncommon.When the doctor tried to tug the haptic off, it was very stuck (tenacious) and did not pop off like usual.When the doctor did get it to pop off, there was a chunk of something left on the haptic that looked stringy, like rubber cement as he pulled it away.The doctor could not pull the glob off the haptic and it ended up in the periphery of the patient¿s eye.The doctor felt it was too risky at this point to try to remove the glob.It was indicated that there is a small mark on the lens as well where it was attached.The doctor was very disturbed about this issue.It was noted that tiny amount of material remains at anterior lens surface - periphery of optic, no inflammation noted.(doctor dilated patient for 1-week exam).There was no patient injury or complications such as capsule tear reported.There was no medication outside the standard of care prescribed, no vitrectomy required, and no sutures used.The lens remains implanted in patient¿s right eye.The current patient outcome is good, and the reported issue did not impact the patient's visual acuity, no visual issues.The doctor¿s next plan of action is observation as long as recovery normal.No further information was provided.

• 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: 18389193
• MDR Text Key: 331497101
• Report Number: 3012236936-2023-03275
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Race: White