MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TEC EYHANCE TOR II SMPLCTY; LENS, INTRAOCULAR, TORIC OPTICS

Model Number UNK-DIU150

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 10/19/2021

Event Type  malfunction  

Event Description

It was reported that after following the direction for use and during implantation of the lens, there was a string of hair or plastic, maybe nylon with an intraocular lens (iol).The surgeon aspirated the string out of the eye, but was not able to collect it.The surgeon thinks that it was not from the healon because it was attached to the lens.No patient issues reported.No additional information was provided.

Manufacturer Narrative

(b)(6).The intraocular lens (iol) is not returning for evaluation.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.Device manufacture date: unknown, as the serial number was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section h3 - device evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) was not returned for evaluation as it was discarded.Therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.However, a 43 second video was provided to the complaint file and was assessed.The video shows an iol implantation process, starting at iol unfolding step.At second 2 a filament motile (not fixated to surfaces) was observed apparently located behind the posterior side of the lens and extending from the center of the eye through the iris edge, at 7:00 meridian.The observed foreign material was removed through aspiration at second 39.The source and nature as well as the potential clinical impact of the observed can not be determined from a video assessment.Manufacturing record evaluation: the manufacturing records for the intraocular lens could not be reviewed as no serial number was provided.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TEC EYHANCE TOR II SMPLCTY
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12817782
• MDR Text Key: 280964259
• Report Number: 2020664-2021-08106
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-DIU150
• Device Catalogue Number: UNK-DIU150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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