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

Model Number DIU150

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth, weight, and ethnicity: unknown, not provided.If implanted; give date: n/a (not applicable).The lens was not implanted and a back up lens was used.If explanted; give date: n/a (not applicable).The lens was not implanted therefore not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the tecnis eyhance preloaded intraocular lens (iol) inserter system seemed to crack when turned and the iol felt rock hard and cracked even after hydration.The surgeon was unable to implant into the patient's eye and had to use a competitive product.No patient injury was reported.No additional information was provided.

Manufacturer Narrative

Device evaluation: product evaluation could not be performed since at the time of this investigation, the product had not been received.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section d9.Device available for evaluation? yes returned to manufacturer on: nov 4, 2021.Section h3.Device evaluated by manufacturer? yes device evaluation: visual inspection under magnification revealed a cartridge crack and a portion of lens sticking out of the crack.The handpiece was disassembled and the lens portion was removed from the cartridge.The lens presented with lens damage.Both complaint issues were confirmed; however, this may be attributed to an inadequate amount of ophthalmoviscoelastic device (ovd), suggested by the lack of ovd in the cartridge and on the lens, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 12580687
• MDR Text Key: 275473624
• Report Number: 2020664-2021-07633
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474746565
• UDI-Public: (01)05050474746565(17)240525
• 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,Followup,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• 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