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

Model Number	DCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: information unknown not provided.If implanted; give date: not applicable.The iol was removed/replaced in the initial surgery.If explanted; give date: not applicable as the iol was removed within the same procedure.Reporter phone number: (b)(6).Device evaluation: the product testing could not be performed as the product was not returned (the device was discarded by the customer).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records and related documents for the production order of the device were reviewed and no discrepancies were found during the mrr (manufacturing record review) related to this complaint.The units were manufactured and released according to specifications.A search in complaint system revealed no additional complaint folders for this production order number.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.
Event or Problem Description
It was reported that the haptic of an intraocular lens (iol) tore off in the eye, during implantation.The lens was removed and a new iol was implanted with good surgery results.There was no patient injury and no surgical complications reported.The iol was discarded in the field.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 02nd september 2021 section h3 - device evaluated by manufacturer? yes device evaluation: the dcb00 product was not received in its original package.The plunger and pushrod was observed in advanced position and in good condition.The pushrod was observed in its correct orientation.Residues of viscoelastic material were observed on cartridge.The cartridge tip was observed deformed.The lens was not returned.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepare for surgical process.The complaint issue reported could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 12316544
• Report Number: 2648035-2021-08186
• Device Sequence Number: 3839833
• Product Code: HQL
• UDI-Device Identifier: 05050474636194
• UDI-Public: (01)05050474636194(17)231210
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 12/10/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1