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

Model Number ICB00

Device Problem Scratched Material (3020)

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

Event Date 12/19/2022

Event Type  malfunction  

Event Description

It was reported that after implantation a scratch/line was detected on the surface of the intraocular lens (iol).The lens remains implanted.Through follow up we learned that the patient is doing well.The doctor hopes the issue will not affect their vision as the scratch/line is outside the center of the iol.There is no further information at this time.

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted, give date: unknown, information not provided.If explanted, give date: not applicable, as the lens remains implanted.Telephone number: (b)(6).The device was not returned for evaluation as the lens remains implanted in the eye.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: product evaluation was performed by our subject matter expert (sme) on customer's provided photographs.The photographs displayed the anterior segment of a pseudophakic eye.A mark/crack can be observed paracentral on the optical portion of the lens.The potential root cause and clinical impact on the patient cannot be determined from a photo assessment.The complaint issue of cosmetic issues was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process as, per manufacturing protocol, the complaint lens is optically inspected for defects prior to being placed in the lens case.Therefore, there is no indication of a product deficiency or product malfunction.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: 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: 16062490
• MDR Text Key: 308350903
• Report Number: 3012236936-2022-03183
• Device Sequence Number: 1
• Product Code: HQL
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICB00
• Device Catalogue Number: ICB00I0210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• 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