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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight and ethnicity: unknown, information not provided.Implant date (2021 reports): if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Explant date (2021 reports): if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Device evaluation: product testing could not be performed since the product was not returned for evaluation as it was discarded.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 specification.A search revealed that four additional complaints were received from this production order and those complaints met the criteria for no further investigation.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) had broken haptic.The intraocular lens (iol) was inspected and then injected into the posterior capsular bag of patient's right eye.As the lens unfolded, it was noted that the haptic was broken.Additional endocoat was injected into the anterior chamber and healon was injected behind the lens implant.The lens was dialed out from the bag.The capsular bag was intact.Another same model and power iol was injected into the bag.Mst forceps and scissors were used to hold and cut the defective lens from the anterior chamber.The lens and a broken haptic were removed through the main incision.Single interrupted 10-0 nylon suture was placed through the main incision.There was a mild subincisional bleeding.Minimal amount of endocoat was used to tamponade it.The wound was gently hydrated and was found to be well-sealed with no leakage as checked with a weck cel and by a drop of betadine 5% over incisions which was then washed out with normal saline.The eye was of a normal physiologic tension.The eye speculum was removed and a drop of vigamox, ketorolac, tetracaine and pred forte placed into the operative eye followed by the shield.The patient tolerated procedure well.No further information was available.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12063319
• Report Number: 2648035-2021-07948
• Device Sequence Number: 3979717
• Product Code: HQL
• UDI-Device Identifier: 05050474558366
• UDI-Public: (01)05050474558366(17)201122
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1