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

Model Number ZA9003

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

It was reported that as the intraocular lens (iol) was unfolding in patient's operative eye, just after implantation, it was noted that the trailing haptic was bent causing the lens not to center in the eye.The lens was cut in half and removed.Another lens was implanted without issues.No other information was provided.

Manufacturer Narrative

Age or date of birth, weight and ethnicity: unknown/ asked but not available.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.The device was not returned for analysis.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, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information received from the facility revealed the following information.The doctor is dr.(b)(6), the eye affected was left eye.There was no patient injury and no intervention was required.The procedure was completed using another lens of same model and diopter.Also, the following fields are updated to reflect additional information.Section a2: age/date of birth: (b)(6), 1954.Section a3: gender: female.Section a4: patient weight: 180 pounds.Section a5: ethnicity/race: hispanic/ latino, white.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: returned to manufacturer on: sep 2, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the complaint lens was received cut in half and with a detached haptic.The remaining haptic was observed to be bent.The lens was cleaned and, no further issues were observed.Conclusion: the complaint issue of "haptic damaged" 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.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 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: 14613773
• MDR Text Key: 300925893
• Report Number: 3012236936-2022-01452
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474528963
• UDI-Public: (01)05050474528963(17)270208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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 Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic
• Patient Race: White